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

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT03136146
Phase
PHASE2
Status
Recruiting
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Conditions

  • Recurrent Acute Lymphoblastic Leukemia
  • Recurrent Adult Lymphoblastic Lymphoma
  • Recurrent Burkitt Leukemia
  • Recurrent Burkitt Lymphoma
  • Recurrent Childhood Lymphoblastic Lymphoma
  • Recurrent High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
  • Refractory Acute Lymphoblastic Leukemia
  • Refractory Burkitt Leukemia
  • Refractory Burkitt Lymphoma
  • Refractory High Grade B-Cell Lymphoma With MYC and BCL2 or BCL6 Rearrangements
  • Refractory Lymphoblastic Lymphoma

Eligibility Criteria

Sex
ALL
Age
15 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Bortezomib — DRUG
    Given SC
  • Clofarabine — DRUG
    Given IV
  • Cyclophosphamide — DRUG
    Given IV
  • Dexamethasone — DRUG
    Given IV or PO
  • Etoposide — DRUG
    Given IV
  • Ofatumumab — BIOLOGICAL
    Given IV
  • Pegfilgrastim — BIOLOGICAL
    Given SC
  • Rituximab — BIOLOGICAL
    Given IV
  • Vincristine Sulfate Liposome — DRUG
    Given IV

Study Details

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.

Key Dates

Start date
Aug 9, 2017
Status verified
Feb 2026
Primary completion
Aug 1, 2027
Completion
Aug 1, 2027

Study Design

Enrollment
42 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Treatment (combination chemotherapy)
    See detailed description

Primary Outcome Measure

Incidence of adverse events [ Time Frame: Up to 8 years ]

Locations (1)

FacilityCityStateZIPSite coordinators
M D Anderson Cancer CenterHoustonTexas77030
Maro Ohanian
[email protected]
713-745-0394
Maro Ohanian (PRINCIPAL_INVESTIGATOR)

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By research site
M D Anderson Cancer Center· Houston, TX

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