← Back to Search

Procedure

Shortened Chemotherapy Before Stem Cell Transplant for Blood Cancers

Phase 1

Recruiting

Led By Michael Scordo, MD

Research Sponsored by Memorial Sloan Kettering Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

- Acute myeloid leukemia (AML) with intermediate or high-risk features in CR1.

Patients aged ≥ 18 years old.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up in the first 30 days post-hct

Awards & highlights

Study Summary

This trial will test a new, shorter chemotherapy regimen for people with blood cancers before a transplant. Researchers want to know if the new regimen has the same or fewer side effects as the current one.

Who is the study for?

Adults with various blood cancers eligible for stem cell transplantation may join this trial. They should have specific types of leukemia, myeloma, or lymphoma responding to therapy, adequate organ function, and not be pregnant or breastfeeding. Those with active brain cancer, uncontrolled infections, recent autologous transplants (except certain myeloma cases), HIV/HTLV, or unwillingness to use contraception are excluded.Check my eligibility

What is being tested?

The study is testing a shortened chemotherapy regimen before allogeneic hematopoietic cell transplantation (Allo-HCT). It involves lower doses of busulfan combined with melphalan and fludarabine plus antithymocyte globulin (ATG) to see if it reduces severe side effects within 30 days post-transplant.See study design

What are the potential side effects?

Potential side effects include reactions related to ATG such as fever and chills; chemotherapy-related nausea, vomiting; low blood counts leading to infection risk; liver dysfunction from busulfan; heart issues from melphalan; and general fatigue.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

My AML is in the first complete remission and is not low risk.

Select...

I am 18 years old or older.

Select...

I am recommended for a stem cell transplant due to my blood cancer.

Select...

My leukemia is in remission but at high risk of returning, or it's in its second or later remission.

Select...

I have been diagnosed with severe aplastic anemia.

Select...

My condition relapsed after my own stem cell transplant or I can't have this type of transplant.

Select...

I have been diagnosed with chronic myelomonocytic leukemia.

Select...

My tests show genetic changes that could lead to a severe type of leukemia.

Select...

My condition worsened after a stem cell transplant or I can't have one.

Select...

My multiple myeloma is high-risk or has relapsed after a stem cell transplant.

Select...

My AML has returned after achieving a second complete remission.

Select...

My condition is not a result of treatment for another cancer.

Select...

My leukemia is in its first or later remission.

Select...

My CML is in an advanced stage but has less than 10% blasts after treatment.

Select...

I do not have life-threatening low blood cell counts.

Select...

My CML is resistant to standard treatments due to a specific mutation.

Select...

I can take care of myself and perform daily activities.

Select...

I did not respond well or was intolerant to specific cancer medication.

Select...

My non-Hodgkin lymphoma has come back after treatment.

Select...

My Hodgkin lymphoma has returned after treatment.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ in the first 30 days post-hct

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~in the first 30 days post-hct

This trial's timeline: 3 weeks for screening, Varies for treatment, and in the first 30 days post-hct for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

the number of grade 4 toxicities

Trial Design

2Treatment groups

Experimental Treatment

Group I: patients with multiple myelomaExperimental Treatment5 Interventions

A. Busulfan 0.8 mg/kg every 6 hours x 10 doses, with dose adjustments made according to PK levels. B. Melphalan (70 mg/m2/day) administered on days -6 and -5. C. Fludarabine (25 mg/m2/day) administered on days -6, -5, -4, -3, -2. All patients receiving matched related or unrelated donor allografts receive anti-thymocyte globulin (ATG) 2.5 mg/kg/day on days -3 and -2 to deplete chemotherapy resistant host T-cells that could hinder engraftment, and it may provide additional GVHD prophylaxis.

Group II: patients hematologic malignancies other than multiple myelomaExperimental Treatment5 Interventions

A. Busulfan 3.2 mg/kg/day, with dose adjustments made according to pharmacokinetic (PK) levels. B. Melphalan (70mg/m2/day) administered on days -6 and -5. C. Fludarabine (25mg/m2/ day) administered on days -6, -5, -4, -3, and -2. All patients receiving matched related or unrelated donor allografts receive anti-thymocyte globulin (ATG) 2.5 mg/kg/day on days -3 and -2 to deplete chemotherapy resistant host T-cells that could hinder engraftment, and it may provide additional GVHD prophylaxis.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Fludarabine

2012

Completed Phase 3

~1100

Melphalan

2008

Completed Phase 3

~1500

0 / 20Eligibility criteria met

Find a Location

Who is running the clinical trial?

Memorial Sloan Kettering Cancer CenterLead Sponsor

1,936 Previous Clinical Trials

588,853 Total Patients Enrolled

1 Trials studying Blood Cancers

25 Patients Enrolled for Blood Cancers

Michael Scordo, MDPrincipal InvestigatorMemorial Sloan Kettering Cancer Center

1 Previous Clinical Trials

62 Total Patients Enrolled

Media Library

Allogeneic hematopoietic cell transplantation (Allo-HCT) (Procedure) Clinical Trial Eligibility Overview. Trial Name: NCT04098393 — Phase 1

Blood Cancers Research Study Groups: patients with multiple myeloma, patients hematologic malignancies other than multiple myeloma

Blood Cancers Clinical Trial 2023: Allogeneic hematopoietic cell transplantation (Allo-HCT) Highlights & Side Effects. Trial Name: NCT04098393 — Phase 1

Allogeneic hematopoietic cell transplantation (Allo-HCT) (Procedure) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04098393 — Phase 1

Frequently Asked Questions

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

How many participants are currently enrolled in this research trial?

"Affirmative. According to clinicaltrials.gov, this research project is presently recruiting participants and was first posted on September 18th2019 with the most recent update taking place on October 3rd 2022. 45 patients are needed from one medical facility."

Answered by AI

In what circumstances is Antithymocyte globulin (ATG) typically administered?

"Antithymocyte globulin (ATG) is often employed to treat severe hodgkin lymphoma. More broadly, it can be utilized as a palliative measure for conditions like chronic lymphocytic leukemia, allogeneic hematopoietic stem cell transplantation, chronic myelogenous leukemia and stem cell transplants."

Answered by AI

What risks come with the use of Antithymocyte globulin (ATG)?

"Our team has attributed a score of 1 to the safety profile of antithymocyte globulin (ATG) due to its limited evidence in clinical trials."

Answered by AI

Is it still possible to volunteer for this experiment?

"Affirmative. The clinicaltrials.gov database indicates that this medical trial, initially posted on September 18th 2019, is still looking for volunteers. Researchers are hoping to enroll 45 patients from a single location."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Giving Chemotherapy for a Shortened Amount of Time Before a Stem Cell Transplantation

2019. "Giving Chemotherapy for a Shortened Amount of Time Before a Stem Cell Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04098393.