Testing Whether High Dose Chemotherapy and Infusion of the Patients' Own Stem Cells Improves Survival in Patients With Peripheral T-cell Lymphoma Who Achieved a Complete Response at the End of the Initial Chemotherapy
Purpose
This phase III trial compares the effect of high dose chemotherapy and the patients' own (autologous) stem cells to observation only in patients with peripheral T-cell lymphoma who achieved a complete response after initial chemotherapy. Usual treatment after a complete response may include observation or high dose chemotherapy followed by an autologous stem cell transplant, however, it is not known if a transplant if beneficial. Giving chemotherapy before a stem cell transplant helps kill cancer cells in the body and helps make room in the patient's bone marrow for new blood-forming cells (stem cells) to grow. Stem cells removed prior to treatment are then returned to the patient to replace the blood forming cells that were destroyed by the chemotherapy. Giving high dose chemotherapy followed by an autologous stem cell transplant may be more effective compared to observation only in treating patients with peripheral T-cell lymphoma who have achieved a complete response after initial chemotherapy.
Conditions
- Anaplastic Large Cell Lymphoma, ALK-Negative
- Follicular Helper T-Cell Lymphoma
- Follicular Helper T-Cell Lymphoma, Angioimmunoblastic-Type
- Peripheral T-Cell Lymphoma, Not Otherwise Specified
Eligibility
- Eligible Ages
- Between 18 Years and 75 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
Criteria
Inclusion Criteria:
- Patient must be 18 to 75 years of age
- Patient must have an Eastern Cooperative Oncology Group (ECOG) performance status
0-2
- Patient must have histologically proven peripheral T-cell lymphoma (PTCL) in one of
the following categories:
- Anaplastic large cell lymphoma (ALCL) ALK-negative
- Angioimmunoblastic T-cell lymphoma (AITL)
- Nodal PTCL with follicular helper T cell (TFH) phenotype
- Peripheral T-cell lymphoma not otherwise specified (PTCL-NOS)
- Patient must have undergone induction treatment with an anthracycline based
chemotherapy.
- NOTE: Patients who discontinued anthracycline during treatment are eligible as
long as they received at least one dose and achieved complete remission
- Patient must have achieved radiologic complete remission following induction therapy
as defined by the Lugano criteria with a Deauville score between 1-3 by PET-CT
- NOTE: There is no central review required. Confirmation of complete remission
status is determined by the enrolling institution's review
- NOTE: If a patient had a positive bone marrow biopsy at the time of initial
diagnosis (pre-induction), a repeat biopsy must be completed post induction to
confirm complete remission (CR)
- Patient must be eligible for high dose chemotherapy and autologous stem cell
transplant (ASCT) per the enrolling institutional guidelines at the transplant
center and be ready to proceed with ASCT if randomized to the ASCT arm
- Patient must not have active infection requiring intravenous systemic antimicrobial
at time of randomization. Antibiotic prophylaxis is acceptable as long as the dose
of the medication has been stable for at least 7 days prior to randomization
- Patients with a prior or concurrent malignancy whose natural history or treatment
does not have the potential to interfere with the safety or efficacy assessment of
the investigational regimen are eligible for this trial
- Patient must not be pregnant or breast-feeding due to the potential harm to an
unborn fetus and possible risk for adverse events in nursing infants with the
treatment regimens being used. All patients of childbearing potential must have a
blood test or urine study within 14 days prior to randomization to rule out
pregnancy. A patient of childbearing potential is defined as anyone, regardless of
sexual orientation or whether they have undergone tubal ligation, who meets the
following criteria: 1) has achieved menarche at some point, 2) has not undergone a
hysterectomy or bilateral oophorectomy; or 3) has not been naturally postmenopausal
(amenorrhea following cancer therapy does not rule out childbearing potential) for
at least 24 consecutive months (i.e., has had menses at any time in the preceding 24
consecutive months)
- Patient must not expect to conceive or father children by using accepted and
effective method(s) of contraception or by abstaining from sexual intercourse during
the treatment phase of the study and thereafter according to institutional
guidelines
- Absolute neutrophil count (ANC) ≥ 1000/mcL (obtained ≤ 14 days prior to protocol
randomization)
- Platelets ≥ 75,000/mcL (obtained ≤ 14 days prior to protocol randomization)
- Total bilirubin ≤ 1.5 x institutional upper limit of normal (ULN) (obtained ≤ 14
days prior to protocol randomization)
- Aspartate aminotransferase (AST)(serum glutamic oxaloacetic transaminase
[SGOT])/alanine aminotransferase (ALT)(serum glutamic pyruvic transaminase [SGPT]) ≤
3.0 x institutional ULN (obtained ≤ 14 days prior to protocol randomization)
- Human immunodeficiency virus (HIV)-infected patients on effective anti-retroviral
therapy with undetectable viral load within 6 months of randomization are eligible
for this trial
- For patients with evidence of chronic hepatitis B virus (HBV) infection, the HBV
viral load must be undetectable on suppressive therapy, if indicated
- Patients with a history of hepatitis C virus (HCV) infection must have been treated
and cured. For patients with HCV infection who are currently on treatment, they are
eligible if they have an undetectable HCV viral load
Study Design
- Phase
- Phase 3
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Treatment
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Active Comparator Arm I (observation) |
Patients receive standard of care observation on study. Patients also undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study. |
|
|
Experimental Arm II (high dose chemotherapy and ASCT) |
Patients receive stem cell mobilization and then undergo leukapheresis per standard of care. Patients also receive high dose chemotherapy followed by ASCT per standard of care. Additionally, patients undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study. |
|
Recruiting Locations
Anchorage, Alaska 98508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Anchorage, Alaska 99508
Phoenix, Arizona 85054
Site Public Contact
855-776-0015
Tucson, Arizona 85719
Tucson, Arizona 85719
Burbank, California 91505
Duarte, California 91010
Irvine, California 92612
Napa, California 94558
Site Public Contact
707-521-3830
Orange, California 92868
Santa Rosa, California 95403
Site Public Contact
707-521-3830
Santa Rosa, California 95405
Site Public Contact
707-521-3830
Lewes, Delaware 19958
Millville, Delaware 19967
Newark, Delaware 19713
Newark, Delaware 19713
Newark, Delaware 19718
Rehoboth Beach, Delaware 19971
Wilmington, Delaware 19801
Jacksonville, Florida 32224-9980
Site Public Contact
855-776-0015
Tampa, Florida 33607
Tampa, Florida 33612
Tampa, Florida 33612
Atlanta, Georgia 30322
Site Public Contact
404-778-1868
Boise, Idaho 83712
Fruitland, Idaho 83619
Meridian, Idaho 83642
Nampa, Idaho 83687
Twin Falls, Idaho 83301
Indianapolis, Indiana 46202
Iowa City, Iowa 52242
Site Public Contact
800-237-1225
Kansas City, Kansas 66160
Overland Park, Kansas 66210
Westwood, Kansas 66205
Louisville, Kentucky 40202
Site Public Contact
502-562-3429
Louisville, Kentucky 40245
New Orleans, Louisiana 70121
Shreveport, Louisiana 71103
Elkton, Maryland 21921
Detroit, Michigan 48201
Farmington Hills, Michigan 48334
Rochester, Minnesota 55905
Site Public Contact
855-776-0015
City of Saint Peters, Missouri 63376
Creve Coeur, Missouri 63141
Kansas City, Missouri 64116
Site Public Contact
913-588-3671
Kansas City, Missouri 64154
Lee's Summit, Missouri 64064
St Louis, Missouri 63110
St Louis, Missouri 63129
St Louis, Missouri 63136
Missoula, Montana 59802
Rochester, New York 14642
Site Public Contact
585-275-5830
Chapel Hill, North Carolina 27599
Charlotte, North Carolina 28203
Site Public Contact
800-804-9376
Charlotte, North Carolina 28204
Clemmons, North Carolina 27012
Site Public Contact
888-716-9259
Durham, North Carolina 27710
Site Public Contact
888-275-3853
Huntersville, North Carolina 28078
Huntersville, North Carolina 28078
Kernersville, North Carolina 27284
Matthews, North Carolina 28105
Matthews, North Carolina 28105
Mooresville, North Carolina 28117
Mount Airy, North Carolina 27030
North Wilkesboro, North Carolina 28659
Salisbury, North Carolina 28144
Stateville, North Carolina 28625
Thomasville, North Carolina 27360
Winston-Salem, North Carolina 27103
Winston-Salem, North Carolina 27157
Site Public Contact
336-713-6771
Athens, Ohio 45701
Columbus, Ohio 43214
Columbus, Ohio 43214
Columbus, Ohio 43215
Columbus, Ohio 43228
Delaware, Ohio 43015
Delaware, Ohio 43015
Dublin, Ohio 43016
Dublin, Ohio 43016
Mansfield, Ohio 44903
Marion, Ohio 43302
Pickerington, Ohio 43147
Westerville, Ohio 43082
Oklahoma City, Oklahoma 73104
Bend, Oregon 97701
Clackamas, Oregon 97015
Coos Bay, Oregon 97420
Hood River, Oregon 97031
Newberg, Oregon 97132
Oregon City, Oregon 97045
Portland, Oregon 97213
Portland, Oregon 97225
Redmond, Oregon 97756
Site Public Contact
541-706-2909
Chadds Ford, Pennsylvania 19317
Danville, Pennsylvania 17822
Wilkes-Barre, Pennsylvania 18711
Charleston, South Carolina 29425
Salt Lake City, Utah 84112
Charlottesville, Virginia 22908
Richmond, Virginia 23298
Aberdeen, Washington 98520
Bellingham, Washington 98225
Centralia, Washington 98531
Edmonds, Washington 98026
Everett, Washington 98201
Issaquah, Washington 98029
Kennewick, Washington 99336
Lacey, Washington 98503
Longview, Washington 98632
Mount Vernon, Washington 98274
Seattle, Washington 98107
Seattle, Washington 98122-5711
Seattle, Washington 98122
Sedro-Woolley, Washington 98284
Spokane, Washington 99202
Spokane, Washington 99216
Spokane, Washington 99218
Vancouver, Washington 98664
Walla Walla, Washington 99362
Madison, Wisconsin 53718
Madison, Wisconsin 53792
Marshfield, Wisconsin 54449
Menomonee Falls, Wisconsin 53051
Site Public Contact
262-257-5100
Milwaukee, Wisconsin 53226
Site Public Contact
414-805-3666
Mukwonago, Wisconsin 53149
New Berlin, Wisconsin 53151
Site Public Contact
414-805-0505
Oak Creek, Wisconsin 53154
Site Public Contact
414-805-0505
Oconomowoc, Wisconsin 53066
Site Public Contact
262-928-7878
Waukesha, Wisconsin 53188
Site Public Contact
262-928-7632
Waukesha, Wisconsin 53188
West Bend, Wisconsin 53095
Site Public Contact
414-805-0505
More Details
- Status
- Recruiting
- Sponsor
- Eastern Cooperative Oncology Group
Detailed Description
PRIMARY OBJECTIVE: I. To demonstrate improvement in progression free survival (PFS) in the autologous stem cell transplant (ASCT) arm compared to the observation arm. SECONDARY OBJECTIVES: I. To assess difference in overall survival (OS) between the observation and autologous stem cell transplant (ASCT) arm. II. To evaluate the differences in study intervention benefit for PFS and OS by the randomization stratification factors (histology and choice of induction chemotherapy). III. To evaluate the cumulative incidence of relapse and mortality between the observational and autologous stem cell transplant (ASCT) arm. EXPLORATORY OBJECTIVE: I. To determine the impact of minimal residual disease (MRD) on the benefit of autologous stem cell transplant (ASCT). OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: Patients receive standard of care observation on study. Patients also undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and computed tomography (CT) or positron emission tomography (PET)/CT throughout the study. ARM II: Patients receive stem cell mobilization and then undergo leukapheresis per standard of care. Patients also receive high dose chemotherapy followed by ASCT per standard of care. Additionally, patients undergo blood sample collection and optional bone marrow aspiration and biopsy on study, and CT or PET/CT throughout the study. After completion of study treatment, patients are followed up every 3 months for 2 years, every 6 months for 3 years, and then yearly for up to 7 years for a total of 12 years from the date of randomization.