Health TrialsbyHealthPanel

Combination Chemotherapy and Nelarabine in Treating Patients With T-cell Acute Lymphoblastic Leukemia or Lymphoblastic Lymphoma

ConditionsT Acute Lymphoblastic LeukemiaT Lymphoblastic Lymphoma
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
AgeNot listed
SponsorM.D. Anderson Cancer Center

About this trial

This phase II trial studies the side effects and how well combination chemotherapy and nelarabine work in treating patients with T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma. Drugs used in chemotherapy, such as cyclophosphamide, vincristine, doxorubicin, dexamethasone, methotrexate, cytarabine, mercaptopurine, prednisone, pegaspargase, nelarabine, and venetoclax work in different ways to stop the growth of cancer cells, either by killing the cells, by stopping them from dividing, or by stopping them from spreading.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Previously untreated T cell ALL including T cell lymphoblastic lymphoma; failure to one induction course of chemotherapy are eligible; patients in CR after =< 2 courses are also eligible

Eastern Cooperative Oncology Group (ECOG) performance status less than or equal to 3

Serum bilirubin less than or equal to 2.0 mg/dL unless considered due to involvement by tumor when an upper limit of 5.0 mg/dL is acceptable

Serum glutamic oxaloacetic transaminase (SGOT) or serum glutamate pyruvate transaminase (SGPT) less than or equal to 4 x upper limit of normal (ULN)

Disqualifiers

Pregnant or nursing women

Trial design

Design model

Single group

Treatments tested in this trial

  • Cyclophosphamide

    Drug

    Given IV

  • Cytarabine

    Drug

    Given IV

  • Dexamethasone

    Drug

    Given IV or PO

  • Doxorubicin Hydrochloride

    Drug

    Given IV

  • Mercaptopurine

    Drug

    Given PO

  • Methotrexate

    Drug

    Given IV and PO

  • Nelarabine

    Drug

    Given IV

  • Pegaspargase

    Drug

    Given IV

  • Prednisone

    Drug

    Given PO

  • Venetoclax

    Drug

    Given PO

  • Vincristine Sulfate

    Drug

    Given IV

Treatment groups

160 Participants
are divided into 1 treatment group
Group A: Treatment (nelarabine and combination chemotherapy)Experimental treatment 11 interventions

Trial outcomes

Primary outcomes

1

Complete remission rate

The sample size will provide an estimate of relapse rate at 3 years with a 95% confidence interval of width +/- 10%.

Time frame
3 years
2

Duration of remission

Duration of remission will be evaluated.

Time frame
Up to 9 years
3

Progression-free survival

Progression-free survival will be estimated.

Time frame
3 years
4

Overall survival

Overall survival will be estimated.

Time frame
3 years

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

M.D. Anderson Cancer Center

Lead sponsor

National Cancer Institute (NCI)

Collaborator

Source ClinicalTrials.gov
Apply now