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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

Study 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.Check my eligibility
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.See study design
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 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.
This trial's timeline: 3 weeks for screening, Varies for treatment, and from start of protocol treatment to death due to any cause, or last follow-up, whichever comes first, assessed up to 2 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
Progression-free Survival at 2 Years
Secondary outcome measures
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
568 Previous Clinical Trials
1,924,588 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,680 Previous Clinical Trials
40,928,512 Total Patients Enrolled
Samer KhaledPrincipal InvestigatorCity of Hope Medical Center

Media Library

Clofarabine (Alkylating agents) Clinical Trial Eligibility Overview. Trial Name: NCT01885689 — Phase 2
Acute Myeloid Leukemia Research Study Groups: Treatment (clofarabine, melphalan, transplant)
Acute Myeloid Leukemia Clinical Trial 2023: Clofarabine Highlights & Side Effects. Trial Name: NCT01885689 — Phase 2
Clofarabine (Alkylating agents) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01885689 — Phase 2

Frequently Asked Questions

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

Has clofarabine been confirmed to meet the standards of regulatory clearance?

"The safety of clofarabine has been evaluated to be a 2, as this clinical trial is in its second phase. Although there is some evidence for the drug's security, no data exists at the moment that fully supports efficacy."

Answered by AI

How is clofarabine typically employed in treatment?

"Clofarabine is typically utilized to treat organ transplantation, as well as dermatitis, atopic rejection, kidney transplants and psoriasis."

Answered by AI

What is the uppermost cap on participants in this experiment?

"This clinical trial is not accepting applicants at the present time. It was initially posted on February 10th 2014 and last updated nearly 8 years later, on February 17th 2022. If you are looking to participate in another medical study, there are 2810 trials with open recruitment for patients suffering from acute myeloid leukemia and 363 studies utilizing clofarabine presently recruiting individuals."

Answered by AI

Are seniors of a certain age qualified to participate in this research study?

"To be included in this medical trial, those enrolling must between 18 and 75 years old. For younger or older patients respectively, there are 950 studies and 2391 studies available."

Answered by AI

What are the eligibility criteria for enrolling in this research trial?

"This clinical trial is accepting participants aged between 18 and 75 with acute myeloid leukemia. Approximately 77 patients are being sought for this medical investigation."

Answered by AI

Is it currently feasible to enlist for this investigation?

"As per clinicaltrials.gov, this specific medical experiment is no longer recruiting participants as it was last updated on February 17th 2022. Despite that fact, there are many other trials actively searching for test subjects right now - 3173 to be exact!"

Answered by AI

Have any other scientific experiments utilized clofarabine?

"At present, there are 363 active clinical trials for clofarabine with 49 in Phase 3. Numerous sites from San Antonio, Texas to the far reaches of America are hosting studies on this drug, amounting to 3885 locations participating overall."

Answered by AI
~6 spots leftby May 2025