AML Therapy With Irradiated Allogeneic Cells

NCT02105116 | Terminated Results

• 4 other identifiers: Pro2013002693NCI-2013-02408021208P30CA072720
• Study Type: interventional
• Target: 6
• Locations: 1 country
• Sites: 1

Brief Summary

This pilot clinical trial studies if cells donated by a close genetic relative can help maintain acute myeloid leukemia (AML) complete remission (CR). Eligible patients will receive a standard induction chemotherapy. If a complete remission results they will receive irradiated allogeneic cells from a HLA haploidentical relative. Only patients who obtain a CR after the standard induction chemotherapy are eligible for the experimental therapy (irradiated haploidentical cells).

Conditions

Adult Acute Megakaryoblastic Leukemia (M7); Adult Acute Minimally Differentiated Myeloid Leukemia (M0); Adult Acute Monoblastic Leukemia (M5a); Adult Acute Monocytic Leukemia (M5b); Adult Acute Myeloblastic Leukemia With Maturation (M2); Adult Acute Myeloblastic Leukemia Without Maturation (M1); Adult Acute Myeloid Leukemia With 11q23 (MLL) Abnormalities; Adult Acute Myeloid Leukemia With Del(5q); Adult Acute Myeloid Leukemia With Inv(16)(p13;q22); Adult Acute Myeloid Leukemia With t(16;16)(p13;q22); Adult Acute Myeloid Leukemia With t(8;21)(q22;q22); Adult Acute Myelomonocytic Leukemia (M4); Adult Erythroleukemia (M6a); Adult Pure Erythroid Leukemia (M6b); Recurrent Adult Acute Myeloid Leukemia; Untreated Adult Acute Myeloid Leukemia

Outcome Measures

Primary Outcomes (3)

• Adverse Events Related to Experimental Therapy

  Patients will be observed for incidence of adverse events related to experimental therapy, graded according to the National Cancer Institute Common Terminology Criteria for Adverse Events version 4.0. Of the 6 patients enrolled, all were ineligible to enter the experimental treatment phase of the study because of failure to reach complete remission. None of the enrolled patients received experimental therapy (allogeneic donor lymphocyte therapy). The one death occurred while receiving standard therapy prior to eligibility for experimental allogeneic therapy. The remained of patients were ineligible for experimental therapy because they did not obtain a complete remission after standard induction chemotherapy.

  Up to 2 years

• Response Rate, Determined by Allogeneic Cell Therapy-related Mortality

  Patients' response rate will be determined by allogeneic cell therapy-related mortality. Of the 6 patients enrolled, all were ineligible to enter the experimental treatment phase of the study for failure to reach complete remission. Hence no outcomes are available.

  Up to 2 years

• Response Rate, Determined by Duration of Complete Remission

  Patients will be scored as being in continuous remission at 2 years or having relapsed sooner. Of the 6 patients enrolled, all were ineligible to enter the treatment phase of the study for failure to reach complete remission for allogenic treatment.

  Up to 2 years

Secondary Outcomes (1)

• Progression Free Survival Probability for CR

  At 2 years

Study Arms (1)

Standard chemotherapy followed by allogenic therapy

EXPERIMENTAL

INDUCTION CHEMOTHERAPY: Patients receive standard induction chemotherapy with fludarabine phosphate IV over 1 hour QD for 5 days and cytarabine IV over 4 hours for 5 days. G-CSF 5 mcg/kg will be started at day14 if day14 bone marrow does not have \>5% leukemic blasts. Treatment may continue for 1 or 2 courses at the discretion of the treating physician. If the patient enters a complete remission they are eligible for ALLOGENEIC CELLULAR THERAPY: Patients eligible for the experimental therapy undergo irradiated Donor Lymphocyte Infusion (DLI) of 3 x 10\^8 CD3+ cells/kg at 8 weeks. Patients with stable disease may repeat irradiated DLI every 8-12 weeks in the absence of disease progression or unacceptable toxicity.

Drug: fludarabine phosphate; Drug: cytarabine; Biological: donor lymphocytes; Other: laboratory biomarker analysis; Drug: G-CSF

Interventions

fludarabine phosphate DRUG

Given IV

Also known as: 2-F-ara-AMP, Beneflur, Fludara

Standard chemotherapy followed by allogenic therapy

cytarabine DRUG

Given IV

Also known as: ARA-C, arabinofuranosylcytosine, arabinosylcytosine, Cytosar-U, cytosine arabinoside

Standard chemotherapy followed by allogenic therapy

donor lymphocytes BIOLOGICAL

Undergo infusion of donor lymphocytes

Standard chemotherapy followed by allogenic therapy

laboratory biomarker analysis OTHER

Correlative studies

Standard chemotherapy followed by allogenic therapy

G-CSF DRUG

Given IV

Also known as: Filgrastim, Neupogen®

Standard chemotherapy followed by allogenic therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Histologically proven non-M3 AML:
• Refractory/relapsed AML OR
• Initial diagnosis of AML in patient \>= 60 years old
• Total bilirubin =\< 1.5 times upper limit of normal (ULN) institutional limits (unless Gilbert's disease)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2.5 X institutional ULN
• Cardiac left ventricular ejection fraction (LVEF) \>= 35%
• Serum creatinine =\< 1.5 mg/dl
• Any organ dysfunction thought to be secondary to disease will be considered separately and the patient will be included at the investigators discretion
• Patients must give informed consent
• Eastern Cooperative Oncology Group (ECOG) performance status =\< 3
• Must have a potential haploidentical donor (parent, sibling, child)
• Patient must have documented CR or CRp after 1 or 2 cycles of fludarabine + cytarabine
• Patient must not be a candidate for an allo-hematopoietic stem cell transplant (HSCT)
• Patient must have a partially (\>= 3/6 class I antigen) human leukocyte antigen (HLA)-matched (by serology or low resolution deoxyribonucleic acid \[DNA\] testing) relative able to serve as a donor
• Patients must not have active uncontrolled infections, other medical or psychological/social conditions that might increase the likelihood of patient adverse effects or poor outcomes

You may not qualify if:

• History of current or prior medical problems that the investigator feels will prevent administration of therapy or assessment of response due to excess toxicity
• Patients with known active central nervous system (CNS) leukemia will be excluded from this clinical study
• Known HIV-positive patients are excluded from the study
• Patients may not be pregnant or breast feeding

Sponsors & Collaborators

• Rutgers, The State University of New Jersey: lead
• National Cancer Institute (NCI): collaborator
• Rutgers Cancer Institute of New Jersey: collaborator

Study Sites (1)

Rutgers Cancer Institute of New Jersey

New Brunswick, New Jersey, 08903, United States

Location

MeSH Terms

Conditions

Leukemia, Megakaryoblastic, Acute; Leukemia, Monocytic, Acute; Leukemia, Myeloid, Acute; Congenital Abnormalities; Leukemia, Myelomonocytic, Acute; Leukemia, Erythroblastic, Acute

Interventions

fludarabine phosphate; Cytarabine; Granulocyte Colony-Stimulating Factor; Filgrastim

Condition Hierarchy (Ancestors)

Leukemia, Myeloid; Leukemia; Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Myeloproliferative Disorders; Bone Marrow Diseases

Intervention Hierarchy (Ancestors)

Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Arabinonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors

Results Point of Contact

• Title: Roger Strair, MD, PhD
• Organization: Rutgers Cancer Institute of New Jersey

strairrk@cinj.rutgers.edu

732-235-7298

Study Officials

• Roger Strair, MD, PhD

  Rutgers Cancer Institute of New Jersey

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

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: Professor of Medicine, RWJMS

Study Record Dates

• First Submitted: April 2, 2014
• First Posted: April 7, 2014
• Study Start: February 1, 2014
• Primary Completion: December 16, 2015
• Study Completion: December 16, 2015
• Last Updated: August 24, 2021
• Results First Posted: July 26, 2018

Record last verified: 2021-08

Locations

US (1)