Donor Peripheral Stem Cell Transplant in Treating Patients With Relapsed Acute Myeloid Leukemia

NCT00274846 | Completed Phase 2 Results DMC

• 3 other identifiers: CDR0000450852UMN-2004LS073UMN-MT2004-25
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Giving chemotherapy before a donor peripheral blood stem cell transplant helps stop the growth of cancer cells. It also helps stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells and natural killer (NK) cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. PURPOSE: This clinical trial is studying how well a peripheral stem cell transplant using NK cells from a donor works in treating patients with relapsed acute myeloid leukemia.

Conditions

Leukemia

Keywords

recurrent adult acute myeloid leukemia; recurrent childhood acute myeloid leukemia; secondary acute myeloid leukemia; adult acute myeloid leukemia with 11q23 (MLL) abnormalities; adult acute myeloid leukemia with inv(16)(p13;q22); adult acute myeloid leukemia with t(15;17)(q22;q12); adult acute myeloid leukemia with t(16;16)(p13;q22); adult acute myeloid leukemia with t(8;21)(q22;q22)

Outcome Measures

Primary Outcomes (1)

• Number of Patients With Natural Killer (NK) Cell Expansion

  Evaluation of expansion of donor allogeneic natural killer (NK) cells at day 14 following infusion (\>100 donor-derived NK cells per uL of patient blood detectable at day +14).

  Study Day 14

Secondary Outcomes (4)

• Number of Patients With Complete Remission

  Day 28-35

• Median Time to Disease Relapse (Months)

  From 1st Day of treatment until death or receipt of bone marrow transplant.

• Overall Survival Time of Patients With Complete Remission

  From Day 1 of Treatment until death or patient received bone marrow transplant.

• Number of Patients With Complete Remission and Natural Killer Cell Expansion

  Day 14

Study Arms (1)

Intent-to-Treat

EXPERIMENTAL

All patients treated with natural killer (NK) cells (at a dose of 1.5-8 x 10\^7/kg.)

Biological: aldesleukin; Biological: therapeutic allogeneic lymphocytes; Drug: cyclophosphamide; Drug: fludarabine phosphate; Procedure: in vitro treated peripheral blood stem cell transplantation

Interventions

aldesleukin BIOLOGICAL

10 million units three times a week for a total of 6 doses. For any subject less than 45 kilograms the IL-2 will be given at 5 million units per meter squared three times weekly for a total of 6 doses

Also known as: IL-2

Intent-to-Treat

therapeutic allogeneic lymphocytes BIOLOGICAL

Cells infused per kg. 1.5-8.0 x 10\^7/kg Total cells infused(for 70 kg. adult) 1.05 - 5.6 x 10\^9

Also known as: lymphocytes

Intent-to-Treat

cyclophosphamide DRUG

Days -5 and -4: 60 mg/kg

Also known as: Cytoxan

Intent-to-Treat

fludarabine phosphate DRUG

Days -5 through -2: 25 mg/m\^2

Also known as: Fludara

Intent-to-Treat

in vitro treated peripheral blood stem cell transplantation PROCEDURE

Day 0 infuse natural killer cells

Also known as: Natural Killer Cells

Intent-to-Treat

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of acute myeloid leukemia (AML) meeting 1 of the following criteria:
• Primary refractory disease (no complete response \[CR\] after ≥ 2 induction therapies)
• Relapsed disease not in CR after ≥ 1 course of standard reinduction therapy
• Secondary AML from myelodysplastic syndromes
• Disease relapsed ≥ 2 months after transplant and no option of donor lymphocyte infusions (e.g., recipients of autologous or umbilical cord blood transplants)
• Chronic myelogenous leukemia with myeloid blast crisis not in second chronic phase after at least one cycle of standard chemotherapy and imatinib
• Over 60 years of age with relapse within 6 months after completion of last chemotherapy
• Over 60 years of age with blast count \< 30% within 10 days before study entry
• Related HLA-haploidentical natural killer cell donor available
• No severe organ damage (by clinical or laboratory assessment)
• Performance status 50-100%
• No evidence of active infection on chest X-ray
• No active fungal infection

You may not qualify if:

• Active central nervous system (CNS) leukemia
• Pleural effusions large enough to be detectable by chest x-ray
• Pregnant or nursing (positive pregnancy test)
• Fertile patients must use effective contraception
• Less than 60 days since prior transplant
• Less than 3 days since prior prednisone
• Less than 3 days since other prior immunosuppressive medication

Sponsors & Collaborators

• Masonic Cancer Center, University of Minnesota: lead

Study Sites (1)

Masonic Cancer Center

Minneapolis, Minnesota, 55455, United States

Location

Related Publications (1)

• Bachanova V, Cooley S, Defor TE, Verneris MR, Zhang B, McKenna DH, Curtsinger J, Panoskaltsis-Mortari A, Lewis D, Hippen K, McGlave P, Weisdorf DJ, Blazar BR, Miller JS. Clearance of acute myeloid leukemia by haploidentical natural killer cells is improved using IL-2 diphtheria toxin fusion protein. Blood. 2014 Jun 19;123(25):3855-63. doi: 10.1182/blood-2013-10-532531. Epub 2014 Apr 9.

  PMID: 24719405 DERIVED

MeSH Terms

Conditions

Leukemia; Leukemia, Myeloid, Acute; Congenital Abnormalities

Interventions

aldesleukin; Interleukin-2; Lymphocyte Count; Cyclophosphamide; fludarabine phosphate; IL32 protein, human

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Interleukins; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Lymphokines; Proteins; Biological Factors; Leukocyte Count; Blood Cell Count; Cell Count; Cytological Techniques; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Hematologic Tests; Investigative Techniques; Cell Physiological Phenomena; Blood Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds

Results Point of Contact

• Title: Jeffrey Miller, M.D.
• Organization: Masonic Cancer Center, University of Minnesota

mille011@umn.edu

612-625-7409

Study Officials

• Jeffrey Miller, MD

  Masonic Cancer Center, University of Minnesota

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 10, 2006
• First Posted: January 11, 2006
• Study Start: March 1, 2005
• Primary Completion: June 1, 2008
• Study Completion: June 1, 2008
• Last Updated: December 28, 2017
• Results First Posted: September 7, 2009

Record last verified: 2017-12

Locations

US (1)