What side effects are associated with this type of intervention?

Common treatments for T-Lymphoblastic Lymphoma/Leukemia, particularly combination chemotherapy, often result in significant side effects. These can include neutropenia (low white blood cell count), which increases infection risk; thrombocytopenia (low platelet count), leading to bleeding issues; and anemia, causing fatigue. Other frequent side effects are mucositis (painful inflammation and ulceration of the mucous membranes lining the digestive tract), immunosuppression, and gastrointestinal symptoms such as nausea and vomiting. Additionally, patients may experience hair loss, liver toxicity, and peripheral neuropathy (nerve damage). Close monitoring and supportive care are essential to manage these adverse effects.

What prior FDA approvals exist?

Nelarabine, a purine analog with T-cell specific action, has been approved by the FDA for the treatment of relapsed or refractory T-cell acute lymphoblastic leukemia/lymphoma (T-ALL/LBL). It works by being converted in vivo to ara-GTP, which is particularly effective in T cells. Additionally, clofarabine, a deoxyadenosine analog, has shown efficacy in pediatric patients with relapsed or refractory ALL, including T-ALL, by inhibiting DNA synthesis and repair, leading to cell death. These drugs align with the mechanisms of action being studied in the combination chemotherapy trial, which includes agents like clofarabine, etoposide, and cyclophosphamide that target tumor cells through various pathways.

What other types of research exist?

Promising novel alternatives to combination chemotherapy for T-Lymphoblastic Lymphoma/Leukemia patients include: 1) Tyrosine Kinase Inhibitors (TKIs) such as BCR::ABL1 inhibitors for patients with Philadelphia chromosome-positive (Ph+) ALL/LBL, which have significantly improved outcomes. 2) Immunotherapy agents like blinatumomab, a bispecific T-cell engager (BiTE) antibody, which has shown high rates of minimal residual disease (MRD)-negative complete remission. 3) CAR T-cell therapy, which involves engineering a patient's T-cells to target and kill cancer cells, has shown promising results in relapsed or refractory cases. These therapies offer targeted approaches that may provide better outcomes and fewer side effects compared to traditional chemotherapy.

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Proteasome inhibitor

Combination Chemotherapy for Acute Lymphoblastic Leukemia

Phase 2

Recruiting

Led By Maro Ohanian

Research Sponsored by M.D. Anderson Cancer Center

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age older than 15 years

Relapsed and/or refractory Philadelphia negative acute lymphoblastic leukemia or lymphoblastic lymphoma (Lead-in and Phase II)

Must not have

Active hepatic graft-versus-host disease

Active >= grade 3 peripheral neuropathy

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 8 years

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a combination of chemotherapy drugs to treat patients with certain types of leukemia and lymphoma that have returned or don't respond to usual treatments. The drugs work together to kill cancer cells and stop them from growing. The study aims to see how safe and effective this treatment is.

Who is the study for?

This trial is for people over 15 with certain types of blood cancers like acute lymphoblastic leukemia or Burkitt lymphoma that have returned or are treatment-resistant. Participants need normal liver function, not be pregnant or breastfeeding, and can't have severe nerve damage or active hepatitis B/C.

What is being tested?

The study tests a combination chemotherapy regimen using drugs like clofarabine, etoposide, cyclophosphamide, and others to see how well they work against aggressive blood cancers when previous treatments failed.

What are the potential side effects?

Chemotherapy may cause side effects such as nausea, hair loss, fatigue, increased risk of infection due to low blood cell counts, bleeding problems from low platelets and potential damage to organs like the heart and kidneys.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am older than 15 years.

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My leukemia or lymphoma has returned or didn't respond to treatment and is not Philadelphia chromosome positive.

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My kidneys are functioning well.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have active liver complications from a transplant.

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I have severe nerve damage in my hands or feet.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 8 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 8 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 8 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Incidence of adverse events

Overall response rate (ORR) (Phase II)

Secondary study objectives

Event free survival

Overall survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Treatment (combination chemotherapy)Experimental Treatment9 Interventions

See detailed description

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Dexamethasone

2007

Completed Phase 4

~2650

Pegfilgrastim

2013

Completed Phase 3

~4440

Clofarabine

2007

Completed Phase 3

~1130

Bortezomib

2005

Completed Phase 3

~1410

Vincristine Sulfate Liposome

2010

Completed Phase 3

~2580

Cyclophosphamide

2010

Completed Phase 4

~2310

Ofatumumab

2013

Completed Phase 3

~1460

Rituximab

1999

Completed Phase 4

~2990

Etoposide

2010

Completed Phase 3

~2960

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Combination chemotherapy is a common treatment for T-Lymphoblastic Lymphoma/Leukemia, utilizing multiple drugs that work through various mechanisms to combat the disease. These drugs include agents like clofarabine, etoposide, cyclophosphamide, vincristine sulfate liposome, dexamethasone, and bortezomib. They kill tumor cells by inducing apoptosis, inhibit cell division by interfering with DNA replication and mitosis, and prevent the spread of cancer cells by disrupting cellular processes essential for metastasis. This multifaceted approach is vital for T-Lymphoblastic Lymphoma/Leukemia patients due to the aggressive nature of the disease, aiming to improve survival rates and reduce the likelihood of relapse.