Recruiting
Phase 2

Combination Chemotherapy

Sponsor:

M.D. Anderson Cancer Center

Code:

NCT03136146

Conditions

Recurrent Acute Lymphoblastic Leukemia

Recurrent Adult Lymphoblastic Lymphoma

Recurrent Burkitt Leukemia

Recurrent Burkitt Lymphoma

Recurrent Childhood Lymphoblastic Lymphoma

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

Interventions

Bortezomib

Clofarabine

Cyclophosphamide

Dexamethasone

Etoposide

Study Details

Brief summary:

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

Recurrent Acute Lymphoblastic Leukemia

Recurrent Adult Lymphoblastic Lymphoma

Recurrent Burkitt Leukemia

Recurrent Burkitt Lymphoma

Recurrent Childhood Lymphoblastic Lymphoma

Study ID

NCT03136146

Start date

Aug 9, 2017

Status verified date

Aug, 2026

Completion date

Aug 1, 2027

Anticipated

Primary completion date

Aug 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 15+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Relapsed/refractory acute lymphoblastic leukemia (ALL) or lymphoblastic lymphoma (LL):

  • Relapsed and/or refractory Philadelphia negative acute lymphoblastic leukemia or lymphoblastic lymphoma (LL) (Lead-in and Phase II)
  • Relapsed and/or refractory Philadelphia positive acute lymphoblastic leukemia, Burkitt leukemia/lymphoma or "double-hit" leukemia/lymphoma (phase II only)
  • At least 21 days elapsed from prior systemic chemotherapy (at least 14 days elapsed from prior systemic chemotherapy in the setting of rapidly progressive disease without significant residual extramedullary toxicity). Hydroxyurea and dexamethasone permitted up to approximately 24 hours prior to the start of therapy. Interruption of tyrosine kinase inhibitor (TKI) not required in Ph positive ALL subset
  • Age older than 15 years
  • Eastern Cooperative Oncology Group (ECOG) performance status =< 3 (There may be certain patients with performance status \[PS\] 3 in the context of rapidly proliferative/refractory ALL who would benefit from this regimen. We don't want to exclude such patients who may derive benefit from this salvage regimen)
  • Serum bilirubin =< 1.5 mg/dL
  • Serum glutamate pyruvate transaminase (SGPT) =< 3 x upper limit normal (ULN), with exception for Gilbert's syndrome
  • Estimated creatinine clearance or GFR (glomerular filtration rate) >= 50 mL/min
  • Signed informed consent

Exclusion Criteria:

  • Active >= grade 3 peripheral neuropathy
  • Active hepatic graft-versus-host disease
  • Known positivity for hepatitis B or C
  • Pregnancy
  • Breast feeding

Study Design

Enrollment

42 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Treatment (combination chemotherapy)

See detailed description

Interventions

Bortezomib

Given SC

Clofarabine

Given IV

Cyclophosphamide

Given IV

Dexamethasone

Given IV or PO

Etoposide

Given IV

Ofatumumab

Given IV

Pegfilgrastim

Given SC

Rituximab

Given IV

Vincristine Sulfate Liposome

Given IV

Primary outcome measure

  • Incidence of adverse events [ Time Frame: Up to 8 years ]
  • Overall response rate (ORR) (Phase II) [ Time Frame: Up to 8 years ]

Central Contacts and Locations

Locations

M D Anderson Cancer Center

Recruiting

Houston, Texas, United States, 77030

Contacts

Maro Ohanian

713-745-0394MOhanian@mdanderson.org

Principal Investigator:

Maro Ohanian

More Information

Sponsor

M.D. Anderson Cancer Center

Last update posted

Aug 10, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by M.D. Anderson Cancer Center on 2026-08-10.