9350 Participants Needed

Chemotherapy for Leukemia and Lymphoma

Recruiting at 257 trial locations
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Pivotal Trial (Near Approval)This treatment is in the last trial phase before FDA approval
Prior Safety DataThis treatment has passed at least one previous human trial

What You Need to Know Before You Apply

What is the purpose of this trial?

This partially randomized phase III trial studies the side effects of different combinations of risk-adapted chemotherapy regimens and how well they work in treating younger patients with newly diagnosed standard-risk acute lymphoblastic leukemia or B-lineage lymphoblastic lymphoma that is found only in the tissue or organ where it began (localized). Drugs used in chemotherapy 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. Giving more than one drug (combination chemotherapy), giving the drugs in different doses, and giving the drugs in different combinations may kill more cancer cells.

Do I need to stop my current medications to join the trial?

The trial protocol does not specify if you need to stop taking your current medications. However, it mentions that patients should not have received any prior cytotoxic chemotherapy for their current diagnosis, except for certain steroid treatments. It's best to discuss your current medications with the trial team.

Is chemotherapy for leukemia and lymphoma generally safe in humans?

Some chemotherapy drugs used for leukemia and lymphoma, like methotrexate, can cause side effects such as mucositis (painful inflammation and ulceration of the mucous membranes lining the digestive tract). Other drugs, like vindesine sulfate, may cause neurotoxicity (nerve damage), alopecia (hair loss), and leucocytopenia (low white blood cell count). These side effects are common but vary in intensity among patients.12345

What makes this chemotherapy treatment for leukemia and lymphoma unique?

This chemotherapy treatment is unique because it combines multiple drugs, including Cyclophosphamide, Cytarabine, Dexamethasone, and others, which are not typically used together in standard regimens. This combination aims to target cancer cells more effectively by using different mechanisms of action, potentially offering a new option for patients who do not respond to conventional treatments.678910

What data supports the effectiveness of the drug combination used in the chemotherapy for leukemia and lymphoma?

Research shows that similar drug combinations, like those including cyclophosphamide, doxorubicin, vincristine, and prednisone (CHOP), are used effectively in treating aggressive lymphomas. These combinations have been shown to improve survival rates in patients with non-Hodgkin's lymphoma.67111213

Who Is on the Research Team?

AL

Anne L Angiolillo

Principal Investigator

Children's Oncology Group

Are You a Good Fit for This Trial?

This trial is for young patients with newly diagnosed standard-risk acute lymphoblastic leukemia or localized B-lineage lymphoblastic lymphoma. They must not have had previous cancer treatments, except certain steroids or intrathecal cytarabine. Patients need to agree to use effective contraception if applicable and meet all study requirements.

Inclusion Criteria

Your white blood cell count at the start of the study should be less than 50,000 cells per microliter.
All patients and/or their parents or legal guardians must sign a written informed consent
B-ALL patients must be enrolled on AALL08B1 or APEC14B1 (if open for the classification of newly diagnosed ALL patients) prior to treatment and enrollment on AALL0932
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Exclusion Criteria

I haven't had chemotherapy for my current B-ALL/B-LLy or any cancer before starting the AALL0932 protocol, except for steroids or intrathecal cytarabine.
Lactating females unless they have agreed not to breastfeed their infants
I am not pregnant or have a negative pregnancy test if of childbearing age.
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Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Therapy

Patients receive a combination of intrathecal cytarabine, vincristine sulfate, dexamethasone, pegaspargase, and methotrexate to induce remission

4 weeks
Weekly visits for drug administration

Consolidation Therapy

Patients receive vincristine sulfate, mercaptopurine, and methotrexate to consolidate remission

4 weeks
Weekly visits for drug administration

Interim Maintenance I

Patients receive vincristine sulfate and methotrexate to maintain remission

8 weeks
Visits on days 1, 11, 21, 31, and 41

Delayed Intensification

Patients receive a combination of dexamethasone, vincristine sulfate, doxorubicin hydrochloride, pegaspargase, cyclophosphamide, thioguanine, and cytarabine to intensify treatment

8 weeks
Frequent visits for drug administration

Interim Maintenance II

Patients receive vincristine sulfate and methotrexate to maintain remission

8 weeks
Visits on days 1, 11, 21, 31, and 41

Maintenance Therapy

Patients receive vincristine sulfate, dexamethasone, methotrexate, and mercaptopurine to maintain remission over a long-term period

2-3 years
Courses repeat every 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

10 years

What Are the Treatments Tested in This Trial?

Interventions

  • Cyclophosphamide
  • Cytarabine
  • Dexamethasone
  • Doxorubicin Hydrochloride
  • Leucovorin Calcium
  • Mercaptopurine
  • Methotrexate
  • Pegaspargase
  • Thioguanine
  • Vincristine Sulfate
Trial Overview The trial tests different combinations of chemotherapy drugs on younger patients with specific types of leukemia or lymphoma. It aims to find the best mix and dosage that kills the most cancer cells while monitoring side effects through various stages of treatment.
How Is the Trial Designed?
8Treatment groups
Experimental Treatment
Group I: Arm SR DS (12-week cycle maintenance)Experimental Treatment13 Interventions
Group II: Arm LR-M (risk-adapted chemotherapy)Experimental Treatment8 Interventions
Group III: Arm LR-C (risk-adapted chemotherapy)Experimental Treatment12 Interventions
Group IV: Arm D (risk-adapted chemotherapy)Experimental Treatment7 Interventions
Group V: Arm C (risk-adapted chemotherapy)Experimental Treatment7 Interventions
Group VI: Arm B-LLy (4-week cycle maintenance)Experimental Treatment13 Interventions
Group VII: Arm B (risk-adapted chemotherapy)Experimental Treatment7 Interventions
Group VIII: Arm A (risk-adapted chemotherapy)Experimental Treatment7 Interventions

Cyclophosphamide is already approved in United States, European Union, Canada, Japan for the following indications:

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Approved in United States as Cytoxan for:
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Approved in European Union as Endoxan for:
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Approved in Canada as Neosar for:
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Approved in Japan as Endoxan for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials
467
Recruited
241,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+

Published Research Related to This Trial

In a phase I pilot study involving 18 patients with refractory lymphoid malignancies, the MILD chemotherapy regimen (methotrexate, ifosfamide, l-asparaginase, and dexamethasone) demonstrated a 57% overall response rate, with complete responses in 3 patients and partial responses in 4 patients.
The treatment was generally feasible with acceptable toxicity, although one patient experienced treatment-related death from systemic mucormycosis, and significant hematologic toxicities were observed, particularly in patients with T/NK-cell malignancies.
Activity and safety of combination chemotherapy with methotrexate, ifosfamide, l-asparaginase and dexamethasone (MILD) for refractory lymphoid malignancies: a pilot study.Tsukune, Y., Isobe, Y., Yasuda, H., et al.[2013]
Pegfilgrastim significantly reduces the incidence of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN) compared to no prophylaxis, with evidence from 41 studies including randomized controlled trials and observational studies.
The efficacy and safety profiles of other long-acting G-CSFs, such as lipegfilgrastim and balugrastim, are comparable to pegfilgrastim, although results for other long-acting G-CSFs were mixed.
Efficacy, effectiveness and safety of long-acting granulocyte colony-stimulating factors for prophylaxis of chemotherapy-induced neutropenia in patients with cancer: a systematic review.Pfeil, AM., Allcott, K., Pettengell, R., et al.[2021]
In a study of 389 young patients with good-prognosis aggressive lymphoma, the high dose of CHOEP-21 did not improve event-free or overall survival compared to the standard CHOEP-21 regimen, indicating no clinical benefit from the increased dosage.
The high CHOEP regimen was associated with significantly higher toxicity, including increased rates of severe leukocytopenia, thrombocytopenia, infections, and therapy-related deaths, suggesting that the risks may outweigh any potential benefits.
Dose-escalated CHOEP for the treatment of young patients with aggressive non-Hodgkin's lymphoma: II. Results of the randomized high-CHOEP trial of the German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL).Pfreundschuh, M., Zwick, C., Zeynalova, S., et al.[2020]

Citations

Activity and safety of combination chemotherapy with methotrexate, ifosfamide, l-asparaginase and dexamethasone (MILD) for refractory lymphoid malignancies: a pilot study. [2013]
Advanced diffuse non-Hodgkin's lymphoma. Analysis of prognostic factors by the international index and by lactic dehydrogenase in an intergroup study. [2019]
Elderly patients with aggressive non-Hodgkin's lymphoma treated with CHOP chemotherapy plus granulocyte-macrophage colony-stimulating factor: identification of two age subgroups with differing hematologic toxicity. [2017]
Cognitive impairment and elevated peripheral cytokines in breast cancer patients receiving chemotherapy. [2023]
Risk of acute leukemia following epirubicin-based adjuvant chemotherapy: a report from the National Cancer Institute of Canada Clinical Trials Group. [2013]
Efficacy, effectiveness and safety of long-acting granulocyte colony-stimulating factors for prophylaxis of chemotherapy-induced neutropenia in patients with cancer: a systematic review. [2021]
Antimetabolite-based therapy in childhood T-cell acute lymphoblastic leukemia: a report of POG study 9296. [2009]
[Administration of vindesine sulfate for the treatment of malignant hematological tumors]. [2015]
Efficacy and tolerability of granulocyte colony-stimulating factors in cancer patients after chemotherapy: A systematic review and Bayesian network meta-analysis. [2021]
10.United Statespubmed.ncbi.nlm.nih.gov
Genetic and metabolic determinants of methotrexate-induced mucositis in pediatric acute lymphoblastic leukemia. [2018]
Dose-escalated CHOEP for the treatment of young patients with aggressive non-Hodgkin's lymphoma: II. Results of the randomized high-CHOEP trial of the German High-Grade Non-Hodgkin's Lymphoma Study Group (DSHNHL). [2020]
12.Russia (Federation)pubmed.ncbi.nlm.nih.gov
[Comparative evaluation of the efficacy of polychemotherapeutic combinations in mycosis fungoides]. [2015]
Effect of granulocyte colony-stimulating factor administration in elderly patients with aggressive non-Hodgkin's lymphoma treated with a pirarubicin-combination chemotherapy regimen. Groupe d'Etudes des Lymphomes de l'Adulte. [2020]
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