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Results summary of St. Jude clinical trial: 

REFLEX

 
 

Haploidentical Hematopoietic Stem Cell Transplantation Using A Novel Clofarabine Containing Conditioning Regimen For Patients With Refractory Hematologic Malignancies

Why was this study done?

When blood cancer relapses or does not respond to standard treatment, the cancer is difficult to treat or cure. One option for treatment is  a stem cell transplant. A family member who is not a perfect match is often used for these patients, since only one out of every three patients has a matched donor available. The transplants can occur more rapidly, since the time to find unrelated donors may take up three or four months.

For these patients, we need new treatments that kill the leukemia cells with fewer long-term side effects and quicker immune recovery time.

We wanted to study the safety of a chemo drug called clofarabine when given with a stem cell transplant. We also wanted to find out the highest dose of clofarabine that can be given safely with a stem cell transplant and whether the transplant would work.

The study’s main goals were to:

  • improve the survival rate
  • find out the safest dose of clofarabine that can be given
  • learn how the donor stem cells begin to grow in the body after transplant
  • find out how often children who receive this therapy get graft-versus-host disease (GVHD)
  • find out the effects (good and bad) of this procedure
  • see if there is a difference in the immune system of patients who develop GVHD as compared to those who do not develop GVHD

When was this study done?

The study opened in January 2009 and closed in October 2016.

What did the study consist of?

  • The patient received a conditioning treatment that included clofarabine.
  • A family member donated stem cells.
  • The stem cells were processed and filtered.
  • These stem cells were transplanted (infused) into the patient.

What did we learn from this study?

Patients tolerated clofarabine well at a dose of 50 mg/m2  given through the vein every day for five days. All patients had rapid recovery of their blood cells after the stem cells from the donor populated their bone marow. 

Only two of the 13 patients in the study died of treatment-related causes. Unfortunately, the relapse rate (recurrence of the disease) remained very high.

What are the next research steps as a result of this study?

Higher doses of clofarabine seemed to be more effective at controlling disease than lower doses. A study with a larger group of patients is needed to further explore that possibility.

How does this study affect my child?

Every childhood cancer survivor should receive long-term follow-up care. Through the St. Jude After Completion of Care clinic, your child will receive information and guidance for care after treatment. Please speak with your St. Jude doctor about specific guidelines that apply to your child.

For more information

Please talk with your child’s St. Jude doctor about questions or concerns you have as a result of this study.

Publication generated from this study:

Haploidentical Donor Transplantation Using a Novel Clofarabine-Containing Conditioning Regimen for Very High-Risk Hematologic Malignant Neoplasms. Sharma A, Kang G, Sunkara A, Hiroto Inaba H, Jeha S, Cross SJ, Geiger T, Triplett B. J Pediatr Hematol Oncol. 2018 Nov; 40(8): e479–e485.
https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6197927