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CAR T-cell Therapy

Treatment (peripheral blood stem cell transplantation) for Chronic Myelogenous Leukemia

Phase 1
Waitlist Available
Led By Samer Srour
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 3 years
Awards & highlights

Study Summary

This trialstudies a new stem cell transplant method to reduce graft-versus-host disease in patients w/hematologic diseases. T cells from donor blood are selected to help.

Eligible Conditions
  • Chronic Myelogenous Leukemia (CML)
  • Acute Myeloid Leukemia
  • Aplastic Anemia
  • Lymphoblastic Lymphoma
  • Myelodysplastic Syndrome
  • Acute Lymphoblastic Leukemia
  • Chronic Myelogenous Leukemia
  • Chronic Myelomonocytic Leukemia
  • Myeloproliferative Neoplasms
  • Multiple Myeloma
  • Chronic Lymphocytic Leukemia
  • Hodgkin's Lymphoma
  • Non-Hodgkin's Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 3 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 3 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Incidence of treatment failure defined as primary graft failure, grade 3-4 acute graft versus host disease (aGVHD), or non-relapse mortality
Secondary outcome measures
Disease free survival (DFS) time
Immune reconstitution
Incidence of infectious episodes
+1 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: Treatment (peripheral blood stem cell transplantation)Experimental Treatment9 Interventions
Patients receive melphalan IV over 30 minutes on day -6 and fludarabine phosphate IV over 1 hour on days -6 to -3. Patients undergo TBI on day -2 and CD45RA depleted peripheral blood stem cell transplantation on day 0. Patients also receive cyclophosphamide IV over 3 hours on days 3-4. Beginning on day 5, patients receive tacrolimus IV for 2 weeks and PO for at least 4 months. Beginning on day 7, patients receive filgrastim SC daily. Patients with CD20 positive lymphoma may receive rituximab IV on days -13, -6, 1, and 8.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Melphalan
2008
Completed Phase 3
~1500
Total-Body Irradiation
1997
Completed Phase 3
~1180
Filgrastim
2000
Completed Phase 3
~3670
Fludarabine Phosphate
1997
Completed Phase 3
~2390
Peripheral Blood Stem Cell Transplantation
1997
Completed Phase 3
~1330
Rituximab
1999
Completed Phase 4
~1880
Tacrolimus
2011
Completed Phase 4
~4740
Cyclophosphamide
1995
Completed Phase 3
~3770

Find a Location

Who is running the clinical trial?

M.D. Anderson Cancer CenterLead Sponsor
2,973 Previous Clinical Trials
1,789,335 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,665 Previous Clinical Trials
40,925,843 Total Patients Enrolled
Samer SrourPrincipal InvestigatorM.D. Anderson Cancer Center
1 Previous Clinical Trials
54 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
Engineered Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies
2017. "Engineered Donor Stem Cell Transplant in Treating Patients With Hematologic Malignancies". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02960646.
~1 spots leftby Apr 2025
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