Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma
Study of Allogeneic Transplantation in Patients With Cutaneous T-Cell Lymphoma (CTCL)
2 other identifiers
interventional
33
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 lymphoma
Started Sep 2003
Longer than P75 for phase_2 lymphoma
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2003
CompletedFirst Submitted
Initial submission to the registry
July 20, 2007
CompletedFirst Posted
Study publicly available on registry
July 25, 2007
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2015
CompletedResults Posted
Study results publicly available
December 29, 2020
CompletedDecember 29, 2020
December 1, 2020
11.8 years
July 20, 2007
June 30, 2016
December 3, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Participant's Response According to Physician's Global Assessment of Clinical Condition (PGA)
Response defined by Physician's Global Assessment of Clinical Condition (PGA) where Complete Response (CR) is No evidence of disease; 100% improvement; Partial Response (PR), one of following: 1) Very significant clearance ( \> 90% to \< 100%); only traces of disease remains; 2) Significant improvement ( \> 75% to \< 90%); some evidence of disease remain; 3) Intermediate between slight and marked improvement; ( \> 50% to \< 75%); 4) Some improvement ( \> 25% to \< 50%); however, significant evidence of disease remains; Stable Disease (SD): Disease has not changed from baseline condition (+\<25%); Progressive Disease (PD): Disease is worse than at baseline evaluation by \> 25% or more. Response confirmed by a second assessment at least 4 weeks following it. Assessments at baseline, pre and post transplant (100 days) then till disease progression or year one.
Response assessed pre-transplant and 100 days post transplant with follow up at 1 year.
Secondary Outcomes (1)
Average Overall Survival (OS) Length
Baseline to disease progression, followed up to 5 years post transplant
Study Arms (1)
Fludarabine + Melphalan with PBPC
EXPERIMENTALFludarabine 25 mg/m\^2 intravenous (IV) daily for 5 Days prior to Allogeneic Transplant, Melphalan 70 mg/m\^2 IV daily for 2 Days prior to IV Allogeneic Transplant following Fludarabine \& Melphalan. Thymoglobulin 2 mg/kg/day IV on days -3, -2 \& -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
Interventions
25 mg/m\^2 Given By Vein Daily for 5 Days Prior to Allogeneic Transplant.
70 mg/m\^2 Given By Vein Daily for 2 Days Prior to Allogeneic Transplant.
Allogeneic transplant given by vein after completion of Fludarabine and Melphalan.
2 mg/kg/day by vein on days -3, -2 and -1 for patients receiving matched unrelated marrow/stem cells or mismatched related marrow.
Eligibility Criteria
You may qualify if:
- 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 \</= 70 years, Zubrod performance status 0 or 1, left ventricular ejection fraction \>/= 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).
You may not qualify if:
- \) Patients cannot have active central nervous system (CNS) disease.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030, United States
Related Publications (1)
Hosing C, Bassett R, Dabaja B, Talpur R, Alousi A, Ciurea S, Popat U, Qazilbash M, Shpall EJ, Oki Y, Nieto Y, Pinnix C, Fanale M, Maadani F, Donato M, Champlin R, Duvic M. Allogeneic stem-cell transplantation in patients with cutaneous lymphoma: updated results from a single institution. Ann Oncol. 2015 Dec;26(12):2490-5. doi: 10.1093/annonc/mdv473. Epub 2015 Sep 28.
PMID: 26416896DERIVED
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Chitra M. Hosing, Professor, Stem Cell Transplantation
- Organization
- University of Texas (UT) MD Anderson Cancer Center
Study Officials
- PRINCIPAL INVESTIGATOR
Chitra M. Hosing, MD
M.D. Anderson Cancer Center
Publication Agreements
- PI is Sponsor Employee
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 20, 2007
First Posted
July 25, 2007
Study Start
September 1, 2003
Primary Completion
June 1, 2015
Study Completion
June 1, 2015
Last Updated
December 29, 2020
Results First Posted
December 29, 2020
Record last verified: 2020-12