Actively Recruiting

Phase 2
Age: 15Years +
All Genders
NCT03136146

Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia

Led by M.D. Anderson Cancer Center · Updated on 2026-02-17

42

Participants Needed

1

Research Sites

520 weeks

Total Duration

On this page

Sponsors

M

M.D. Anderson Cancer Center

Lead Sponsor

N

National Cancer Institute (NCI)

Collaborating Sponsor

AI-Summary

What this Trial Is About

This phase II trial studies the side effects and how well combination chemotherapy works in treating patients with acute lymphoblastic leukemia, lymphoblastic lymphoma, Burkitt lymphoma/leukemia, or double-hit lymphoma/leukemia that has come back or does not respond to treatment. Drugs used in chemotherapy, such as clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone and bortezomib, work in different ways to stop the growth of tumor cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

CONDITIONS

Official Title

Combination Chemotherapy in Treating Patients With Relapsed or Refractory Acute Lymphoblastic Leukemia, Lymphoblastic Lymphoma, Burkitt Lymphoma/Leukemia, or Double-Hit Lymphoma/Leukemia

Who Can Participate

Age: 15Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Relapsed or refractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL), including Philadelphia negative and Philadelphia positive types, Burkitt leukemia/lymphoma, or double-hit leukemia/lymphoma as specified
  • At least 21 days since prior systemic chemotherapy (14 days allowed for rapidly progressing disease without significant residual toxicity)
  • Hydroxyurea and dexamethasone allowed up to about 24 hours before starting therapy
  • No interruption required for tyrosine kinase inhibitor treatment in Philadelphia positive ALL subset
  • Age older than 15 years
  • Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3
  • Serum bilirubin 1.5 mg/dL or less
  • Serum glutamate pyruvate transaminase (SGPT) less than or equal to 3 times the upper limit normal (ULN), except for Gilbert's syndrome
  • Estimated creatinine clearance or glomerular filtration rate (GFR) of 50 mL/min or higher
  • Signed informed consent
Not Eligible

You will not qualify if you...

  • Active peripheral neuropathy at grade 3 or higher
  • Active hepatic graft-versus-host disease
  • Known positive test for hepatitis B or hepatitis C
  • Pregnancy
  • Breastfeeding

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

M D Anderson Cancer Center

Houston, Texas, United States, 77030

Actively Recruiting

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How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

TREATMENT

Number of Arms

1

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