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Stem Cell Transplantation
Stem Cell Transplant for T-Cell Lymphoma
Phase 2
Recruiting
Led By Jennifer A Kanakry, M.D.
Research Sponsored by National Cancer Institute (NCI)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Pulmonary function tests: DLco (corrected for hemoglobin) and FEV1 greater than or equal to 40% of predicted for the RIC arm, and greater than or equal to 30% predicted for the IOC arm; or in pediatric patients, if unable to perform pulmonary function tests, there should be no evidence of dyspnea at rest, no requirement for supplemental oxygen, and oxygen saturation >92% on room air. Calculations will be based on the USA-ITS-NIH reference.
Estimated creatinine clearance of greater than or equal to 50 mL/min/1.73 m2, calculated using eGFR in the clinical lab for adults and the Schwartz formula for pediatrics.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1, 3, and 5 years post transplant
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing if a stem cell transplant can cure or control lymphoma and if new ways of getting a recipient ready for a transplant may result in fewer problems and side effects.
Who is the study for?
This trial is for people aged 12+ with a type of blood cancer called peripheral T cell lymphoma that hasn't improved with standard treatments. Healthy adults over 18 can be donors if they're related to someone with the condition. Participants need functioning major organs and a matched donor based on specific genetic markers.
What is being tested?
The study tests whether stem cell transplants can cure or control lymphoma, and if new preparation methods reduce complications. Recipients will undergo screening, receive chemotherapy or antibody therapy, get the transplant via catheter, and take medications post-transplant while being closely monitored.
What are the potential side effects?
Potential side effects include reactions to infusions like fever or chills, risk of infection from lowered immunity due to chemotherapy, possible organ inflammation from antibody therapy, discomfort from bone marrow biopsy procedures, and general fatigue after treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lung function tests are within the required range, or I'm a child without breathing issues at rest.
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My kidney function, measured by creatinine clearance, is normal or only slightly reduced.
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I am 12 years old or older.
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My ALK-positive ALCL has not responded to treatment or has come back.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1, 3, and 5 years post transplant
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1, 3, and 5 years post transplant
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Progression-free survival (PFS) of HCT recipients on the IOC arm and ATL-RIC arm
Progression-free survival (PFS) of HCT recipients on the RIC arm and the mRIC arm
Secondary study objectives
GVHD-free graft failure-free survival (GGFS)
GVHD-free relapse-free survival (GRFS)
Incidence of Acute Graft versus-host disease
+11 moreAwards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
5Treatment groups
Experimental Treatment
Active Control
Group I: 5/ATL-RIC ArmExperimental Treatment3 Interventions
modified Reduced Intensity Conditioning Arm for ATL patients, plus allogeneic HCT with GVHD prophylaxis
Group II: 4/mRIC ArmExperimental Treatment3 Interventions
modified Reduced Intensity Conditioning Arm, plus allogeneic HCT with GVHD prophylaxis
Group III: 2/IOC ArmExperimental Treatment3 Interventions
Immunosuppression Only Conditioning, plus allogeneic HCT with GVHD prophylaxis
Group IV: 1/RIC ArmExperimental Treatment3 Interventions
Reduced Intensity Conditioning Arm, plus allogeneic HCT with GVHD prophylaxis
Group V: 3/Donor ArmActive Control1 Intervention
Donors for Recipients in Arm 1, Arm 2, Arm 4, or Arm 5
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GVHD prophylaxis
2008
Completed Phase 2
~140
RIC
2019
N/A
~110
Find a Location
Who is running the clinical trial?
National Cancer Institute (NCI)Lead Sponsor
13,956 Previous Clinical Trials
41,111,872 Total Patients Enrolled
Jennifer A Kanakry, M.D.Principal InvestigatorNational Cancer Institute (NCI)
3 Previous Clinical Trials
1,156 Total Patients Enrolled