Rituximab for Patients With Relapsed Acute Lymphoblastic Leukemia

NCT01230788 | Terminated Results DMC

• 2 other identifiers: IRB00039682Rituximab
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 3

Brief Summary

This is a pilot study of a drug called rituximab used together with other drugs-prednisone, etoposide, and ifosfamide. Prednisone, etoposide, and ifosfamide have been used as part of standard chemotherapy for relapsed Acute Lymphoblastic Leukemia (ALL). Rituximab was approved by the Food and Drug Administration in 1997. However, the use of rituximab with prednisone, etoposide, and ifosfamide in pediatric patients with relapsed or refractory ALL is considered experimental. This study is for patients who have ALL in second or greater relapse, or in first relapse and not responding to treatment. The goals of this study are:

• To see if using rituximab with prednisone, etoposide, and ifosfamide is beneficial to leukemia treatment
• To find out what side effects this combination of drugs can cause A total of 15 participants (30 years old or younger) will be enrolled, over a period of 2 years.

Conditions

Leukemia; Acute Lymphoblastic Leukemia; ALL

Keywords

ALL; Leukemia; Rituximab; Pediatrics

Outcome Measures

Primary Outcomes (3)

• 4 Month Event Free Survival (EFS)

  To estimate the 4 month EFS after therapy with rituximab and cytotoxic chemotherapy (prednisone/etoposide/ifosfamide) in patients with second relapse/refractory ALL.

  one year after enrollment

• Toxicities of Rituximab

  To describe the toxicities of rituximab in addition to prednisone, etoposide, and ifosfamide.

  two months after treatment

• Remission Induction Rate

  To estimate the remission induction rate of the addition of rituximab to cytotoxic chemotherapy (prednisone/etoposide/ifosfamide) in patients with second relapse/refractory ALL.

  one month

Secondary Outcomes (2)

• Minimal Residual Disease

  one month after treatment

• Prednisone Effect

  one month after treatment

Study Arms (1)

rituximab

EXPERIMENTAL

study drug given

Drug: rituximab

Interventions

rituximab DRUG

375 mg/m2/dose on days 8, 15, 22, and 29 (diluted in NS to a final concentration of 1 mg/ml for ease of administration). (Premedicate with Acetaminophen 15 mg/kg po (max 650 mg) and Diphenhydramine 1 mg/kg IV/PO (max 50 mg)).

rituximab

Eligibility Criteria

• Age: 1 Year - 30 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age: Patients must be 1-30 years of age at initial diagnosis.
• Diagnosis: Patients must have histologically-confirmed relapsed/refractory Acute Lymphoblastic Leukemia (ALL).
• Disease Status:Patients must be in
• second or greater bone marrow relapse (≥ 25% blasts by morphology), or
• refractory to reinduction therapy with one or more attempts at remission reinduction (end of reinduction blasts ≥ 5% by morphology and/or end of reinduction MRD ≥ 1% by flow cytometry).
• Patients with combined bone marrow and extramedullary relapse are eligible (CNS 3 patients excluded).
• Performance Status: Patients must have a performance status of ≥50 from the Lansky Scale if \<10 years or ≥ 50 or from the Karnofsky Scale if ≥ 10 years. Patients who are unable to walk because of paralysis, but who are up in a wheelchair will be considered ambulatory for the purpose of assessing the performance score.
• Prior Therapy: Patients must have fully recovered from the acute toxic effects of all prior chemotherapy, immunotherapy, or radiotherapy prior to entering this study and meet time restrictions from end of prior therapy as stated below:
• Myelosuppressive chemotherapy: must not have received within 2 weeks of entry onto this study (4 weeks in the case of nitrosurea containing therapy). Patients who relapse while receiving ALL maintenance chemotherapy will not be required to have a waiting period before entry onto this study. Cytoreduction with hydroxyurea can be initiated and continued for up to 24 hours prior to the start of therapy.
• XRT: must be ≥ 4 weeks since the completion of radiation therapy.
• Study specific limitations: must be ≥ 7 days since the completion of corticosteroid therapy.
• Growth factor(s): Must not have received any hematopoietic growth factors (GCSF, Neulasta, or GMCSF) within 7 days of study entry.
• Stem Cell Transplant: Patients must be at least two months from stem cell transplant, must be off immunosuppressives, and must have no evidence of active graft versus host disease.
• Biologic (anti-neoplastic agent): At least 7 days since the completion of therapy with a biologic agent. For agents that have known adverse events occurring beyond 7 days after administration, this period must be extended beyond the time during which adverse events are known to occur. The duration of this interval must be discussed with the study chair.
• Institutional review board approval.

You may not qualify if:

• Patients with an active and uncontrolled infection, defined as need for pressors, and/or positive cultures for 24 hours.
• Patients recovering from allogeneic bone marrow transplantation who are still on immunosupressants.
• Pregnant or lactating females. Women of childbearing age will agree to use contraception during the protocol.
• Patients currently receiving other investigational agents, medications, or supplements with a known anti-leukemic effect.
• Patients who, in the opinion of the investigator, will not be able to comply with safety monitoring requirements of the study.
• Patients with reactivation of hepatitis B prior to starting therapy.
• Patients who are HIV positive.
• Patients must not have CNS 3 involvement.

Sponsors & Collaborators

• Emory University: lead

Study Sites (3)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

Emory University

Atlanta, Georgia, 30322, United States

Location

The children's Mercy Hospital

Kansas City, Missouri, 64108, United States

Location

MeSH Terms

Conditions

Leukemia; Precursor Cell Lymphoblastic Leukemia-Lymphoma

Interventions

Rituximab

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Leukemia, Lymphoid; Lymphoproliferative Disorders; Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Murine-Derived; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Limitations and Caveats

The one subject was enrolled became a screen failure as she started a prohibited medication prior to going on study.

Results Point of Contact

• Title: Dr. Todd Cooper
• Organization: Emory University

tmcoope@emory.edu

404-785-3000

Study Officials

• Todd Cooper, DO

  Emory University/Children's Healthcare of Atlanta

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 23, 2010
• First Posted: October 29, 2010
• Study Start: September 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: October 1, 2012
• Last Updated: December 1, 2014
• Results First Posted: August 18, 2014

Record last verified: 2014-11

Locations

US (3)