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Alkylating agents
Pre-Transplant Clofarabine + Melphalan for Myelodysplastic Syndrome and Leukemia
Phase 2
Waitlist Available
Led By Samer Khaled
Research Sponsored by City of Hope Medical 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 from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 2 years.
Awards & highlights
Summary
This trial is testing how well clofarabine and melphalan work before a stem cell transplant for patients with myelodysplasia or acute leukemia in remission, or chronic myelomonocytic leukemia.
Who is the study for?
This trial is for patients with myelodysplasia, acute leukemia in remission, or chronic myelomonocytic leukemia who haven't had a previous transplant. They must have good kidney and liver function, heart and lung capacity, an HLA-matched donor available, and be able to understand the study. Pregnant women or those with significant health issues like HIV are excluded.
What is being tested?
The effectiveness of clofarabine and melphalan chemotherapy before receiving stem cells from a donor is being tested. The goal is to see if this treatment can help stop cancer growth while preventing rejection of the new stem cells which could rebuild healthy blood cells.
What are the potential side effects?
Potential side effects include reactions to the drugs such as allergies, damage to organs like kidneys or liver due to toxicity from chemotherapy, increased risk of infections post-transplantation due to immune suppression, and complications related to graft-versus-host disease.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 2 years.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 2 years.
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 at 2 Years
Secondary study objectives
Overall Survival at 2 Years
Trial Design
1Treatment groups
Experimental Treatment
Group I: Treatment (clofarabine, melphalan, transplant)Experimental Treatment6 Interventions
CONDITIONING REGIMEN: Patients receive clofarabine IV over 2 hours on days -9 to -5 and melphalan IV over 30 minutes on day -4.
TRANSPLANT: Patients undergo allogeneic hematopoietic stem cell transplant on day 0.
GVHD PROPHYLAXIS: Beginning on day -3, patients receive tacrolimus IV or PO and sirolimus PO once daily with taper per City of Hope standard operating procedure.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
sirolimus
2006
Completed Phase 4
~1510
clofarabine
2013
Completed Phase 2
~820
melphalan
1994
Completed Phase 3
~3530
allogeneic hematopoietic stem cell transplantation
2005
Completed Phase 3
~890
tacrolimus
2004
Completed Phase 4
~3750
Find a Location
Who is running the clinical trial?
City of Hope Medical CenterLead Sponsor
596 Previous Clinical Trials
1,923,465 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,842 Previous Clinical Trials
41,002,928 Total Patients Enrolled
Samer KhaledPrincipal InvestigatorCity of Hope Medical Center
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- The stem cells used for donation can come from either the blood or the bone marrow.You rely on regular blood transfusions to maintain your health.You have a type of blood disorder called therapy-related MDS or MDS that developed from another blood disorder, except for myelofibrosis.If you have a type of blood disorder called MDS that has turned into AML, you must be in a period where the disease is not active or getting worse.You are allergic to clofarabine, melphalan, sirolimus, or tacrolimus.Using cord blood as a source of donor cells is not allowed.You cannot have other types of cancer that need treatment or might get worse during the study. However, if you had skin cancer, early stage cervical cancer, or early stage prostate cancer before and it's been treated with no signs of the disease left, you may still be able to participate.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment (clofarabine, melphalan, transplant)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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