BECHEM: A Phase I Trial of Bendamustine in Combination with Clofarabine and Etoposide in Pediatric Patients with Relapsed or Refractory Hematologic Malignancies
Why was this study done?
When leukemia or lymphoma returns or is hard to treat, patients need different chemotherapy (chemo) to bring the disease into remission (no signs or symptoms of disease). Previously a three-drug combination of cyclophosphamide, clofarabine and etoposide used to bring about remission, was associated with unwanted side effects. Scientists thought a new drug called bendamustine might be a better option than cyclophosphamide in this combo.
This study’s main goal was to find out if bendamustine would be safe when given with clofarabine and etoposide. Bendamustine had already been used to treat other leukemias and lymphomas. This drug had not been approved for use in children, and it had not been given with the drugs used in this study.
The study’s other goals were to:
- Find the highest dose of bendamustine that could be safely given along with clofarabine and etoposide
- Learn the side effects of the drug combination in these children.
- Find out if this is an effective treatment.
When was this study done?
The study opened in August 2013 and closed in May 2016.
What did the study consist of?
- Patients received the three chemo drugs by vein once a day for five days.
- Another drug called dexamethasone was given by mouth three times a day for five days.
- Patients could receive one more course of this treatment after three weeks if the doctor thought a child needed more treatment.
What did we learn from this study?
Sixteen patients were treated, and 10 of them achieved a remission from their leukemia. We figured out that the best dose of bendamustine when combined with clofarabine and etoposide is 30 mg/m2/ day for 5 days. A common side effect was low blood counts. The study showed that the treatment is safe, effective and well tolerated. Children with B-ALL had the best response rates to this therapy.
What are the next research steps as a result of this study?
More research is needed to continue to improve chemo treatments for patients who relapse after targeted therapies and immunotherapies and for those who are not eligible for such therapies.
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:
Phase 1 Study of Bendamustine in Combination with Clofarabine, Etoposide, and Dexamethasone in Pediatric Patients with Relapsed or Refractory Hematologic Malignancies. Jeha S, Crews KR, Pei D, Peyton M, Panetta JC, Ribeiro RC, Zhao X, Campbell P, Metzger ML, Yang JJ, Cheng C, Pui CH, Bhojwani D. Cancer. 2021 Feb 17. Epub ahead of prInt.