Phase 2
N=33
Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma
Lymphoma · Disorder Related to Bone Marrow Transplantation
Bottom Line
View on ClinicalTrials.gov: NCT00506129 ↗Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Dec 2020
Primary outcome: Primary: Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA) — 19; 6; 0; 0 participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Fludarabine (Drug); Melphalan (Drug); Allogeneic Transplant (Procedure); Thymoglobulin (Drug)
- Age
- Pediatric, Adult, Older Adult
- Sex
- All
- Sponsor
- M.D. Anderson Cancer Center
- Primary completion
- Jun 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA) |
19; 6; 0; 0; 16 | — |
| SECONDARY Average Overall Survival (OS) Length |
1207 | — |
Summary
The goal of this clinical research study is to see if receiving a transplant of blood stem cells (cells that can produce blood) or bone marrow from either a related donor (brother, sister or other relative) or an unrelated voluntary donor will help patients with advanced cutaneous T-cell lymphoma. The length of time that patients who receive the treatment remain free of disease will also be studied.
Eligibility Criteria
Inclusion Criteria
- Patients with pathologically proven cutaneous T-cell lymphoma (CTCL), disease stage IIB to IVB, patients must be in at least a partial response-PR (skin and lymph nodes) after receiving other non-allogeneic transplant therapy, age /= 50% or approved for transplant by a cardiologist, DLCO >/= 50% predicted or approved for transplant by a pulmonologist, serum creatinine </= 1.5 mg/dL, serum bilirubin < 2mg/dL. SGPT < 3 x upper limit of normal, and no previous history of allogeneic transplantation.
- Donor: HLA-compatible related (HLA-A, -B, -DRB1 matched or with one-antigen mismatch) or HLA-compatible unrelated (HLA-A, -B, -C and -DRB1 matched or with one-antigen mismatch).
Exclusion Criteria
- Patients cannot have active central nervous system (CNS) disease.
Data sourced from ClinicalTrials.gov (NCT00506129). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.