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Alkylating Agent

Stem Cell Transplant for Prolymphocytic Leukemia

Phase 1
Waitlist Available
Led By Jonathan Brammer, MD
Research Sponsored by Ohio State University Comprehensive 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 30 days
Awards & highlights

Study Summary

This trial is studying a combination of romidepsin, fludarabine, and busulfan to see if it can help control leukemia or lymphoma. Researchers also want to learn the highest tolerable dose of romidepsin that can be given with this combination.

Eligible Conditions
  • Prolymphocytic Leukemia
  • Peripheral T-Cell Lymphoma
  • Acute Myeloid Leukemia
  • Cutaneous T-Cell Lymphoma
  • T-Cell Lymphoblastic Lymphoma

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~30 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 30 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Efficacy of Romidepsin with Busulfan and Fludarabine Conditioning Therapy for Allogeneic Stem Cell Transplantation
Toxicity of Romidepsin with Busulfan and Fludarabine Conditioning Therapy for Allogeneic Stem Cell Transplantation

Side effects data

From 2010 Phase 2 & 3 trial • 135 Patients • NCT00176904
40%
Death
7%
Auto recovery
1%
Primary graft failure
100%
80%
60%
40%
20%
0%
Study treatment Arm
Patients Treated With Stem Cell Transplant

Trial Design

1Treatment groups
Experimental Treatment
Group I: Romidepsin + Busulfan + Fludarabine + Stem Cell TransplantExperimental Treatment5 Interventions
Part 1: Busulfan administered at the dose calculated to achieve a total (including first two doses delivered on Day -13 and -12) systemic exposure of 20,000 ± 12% µMol-min based on the pharmacokinetic studies. Fludarabine 40 mg/m2 by vein on Days -6 to -3. Romidepsin dosed per actual body weight/actual body surface area. Romidepsin administered on Day -6, -5, -4, and -3 at escalating doses of 1 mg/m2, 2 mg/m2, and 3 mg/m2 by vein to determine the optimal dose. Participants receiving a graft from a matched unrelated donor receive rabbit Thymoglobulin; 0.5 mg/kg on Day -3, 1.5 mg/kg on Day -2 and 2.0 mg/kg on Day -1. Stem cell infusion on Day 0. Romidepsin Maintenance Therapy - Part 2: Starting between Day +28 and Day +100, if participant is eligible based on disease status, they will continue to receive Romidepsin 8 mg/m2 by vein over 1 hour on Day 1 of each 2-week cycle.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Busulfan
2008
Completed Phase 3
~1120
Thymoglobulin
2005
Completed Phase 4
~1500
Romidepsin
2011
Completed Phase 2
~790
Fludarabine
2012
Completed Phase 3
~1100
Stem Cell Transplant
2007
Completed Phase 3
~1350

Find a Location

Who is running the clinical trial?

Ohio State University Comprehensive Cancer CenterLead Sponsor
320 Previous Clinical Trials
290,157 Total Patients Enrolled
Celgene CorporationIndustry Sponsor
444 Previous Clinical Trials
58,226 Total Patients Enrolled
Jonathan Brammer, MDPrincipal Investigator - The Ohio State University Comprehensive Cancer Center
Ohio State University Comprehensive Cancer Center

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What other experimental studies have been conducted in regard to Stem Cell Transplantation?

"Presently, there is a plethora of ongoing studies that explore the effects of Stem Cell Transplant. Out of these 451 research projects, 37 are in Phase 3. Whilst Philadelphia appears to be hosting the most trials for this intervention (371), it is available at 4849 locations across America."

Answered by AI

Are recruitment efforts being made for this clinical trial?

"Affirmative. According to clinicaltrials.gov, this medical study is currently recruiting patients; the trial was initially posted on December 8th 2017 and has been updated as recently as April 18th 2022. The research requires 10 participants from a single institution."

Answered by AI

How many individuals are involved in the current experiment?

"Affirmative, according to the data on clinicaltrials.gov this study is presently recruiting participants. It was initially released on December 8th 2017 and last updated April 18th 2022. This trial requires 10 patients across a single site."

Answered by AI

Has the FDA issued a statement of approval for Stem Cell Transplantation?

"The safety of stem cell transplant is currently rated low, at 1 on the scale due to a lack of clinical data that support its efficacy."

Answered by AI

Am I eligible to participate in this experimental research?

"This clinical trial is looking for 10 individuals aged between 18 and 70 whose diagnosis includes Cutaneous T-Cell Lymphoma, T-Prolymphocytic Leukemia, T-Large Granulocytic Leukemia, T-Lymphoblastic Leukemia/lymphoma or Peripheral T-Cell Lymphoma. Furthermore, applicants must meet the following prerequisites: HLA matched sibling or unrelated donor with a minimum score of 8/8 to 10/10; EF>/= 50% on MUGA scan or Echocardiogram; FEV1, FVC and corrected DLCO >/"

Answered by AI

Does this investigation include individuals past the age of eighty-five?

"This trial is open to applicants aged 18-70. There are 833 studies for those younger than the age of majority and 2861 research projects catering towards adults older than 65 years old."

Answered by AI

To what diseases does Stem Cell Transplant generally provide relief?

"Stem Cell Transplant is an effective treatment for polycythemia vera (pv), as well as immunosuppressive treatments, kidney diseases and allogeneic hematopoietic stem cell transplantation, and chronic myelogenous leukemia."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Romidepsin Maintenance After Allogeneic Stem Cell Transplantation
Jonathan Brammer 2017. "Romidepsin Maintenance After Allogeneic Stem Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02512497.
~1 spots leftby Apr 2025
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