Peginterferon Alfa-2a to Enhance Anti-leukemic Responses After Allogeneic Transplantation in Acute Myeloid Leukemia

NCT ID: NCT02328755

Last Updated: 2021-10-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 37 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-31
• Study Completion Date: 2019-03-25

Brief Summary

This protocol is an open label, single arm, non-randomized, phase I / II clinical trial investigating the use of pegylated interferon alpha-2a (peg-IFN-α, Pegasys®, Genentech) for prevention of relapse in acute myeloid leukemia (AML) not in remission at the time of allogeneic hematopoietic stem cell transplantation (HCT).

Detailed Description

This protocol is an open label, single arm, non-randomized, phase I / II clinical trial investigating the use of pegylated interferon alpha-2a (peg-IFN-α, Pegasys®, Genentech) for prevention of relapse in acute myeloid leukemia (AML) not in remission at the time of allogeneic hematopoietic stem cell transplantation (HCT). The inability to attain remission status following induction therapy for AML remains a significant problem and is associated with poor outcomes. While HCT remains a curative option, its activity in the setting of relapsed or refractory AML is significantly diminished due to high relapse.

Conditions

Acute Myeloid Leukemia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

peg-IFN-α

peg-IFN-α will be administered prior to HCT (Hematopoietic Cell Transplant) and at three subsequent time points post HCT. (Maximum of 4 doses) It will be administered by subcutaneous injection every 14 days beginning with dose level 1.

Dose Level -1 - 45mcg Dose Level 1 - 90mcg Dose Level 2 - 180 mcg

Group Type: EXPERIMENTAL

peg-IFN-α

Intervention Type: DRUG

Hematopoietic Cell Transplant (HCT)

Intervention Type: PROCEDURE

Tacrolimus

Intervention Type: DRUG

Calcineurin inhibitor administered along with HCT for Graft Versus Host Disease (GVHD) prophylaxis. Cyclosporine may be substituted if patients cannot tolerate tacrolimus.

Methotrexate

Intervention Type: DRUG

Administered along with HCT for Graft Versus Host Disease (GVHD) prophylaxis.

Interventions

peg-IFN-α

Intervention Type: DRUG

Hematopoietic Cell Transplant (HCT)

Intervention Type: PROCEDURE

Tacrolimus

Calcineurin inhibitor administered along with HCT for Graft Versus Host Disease (GVHD) prophylaxis. Cyclosporine may be substituted if patients cannot tolerate tacrolimus.

Intervention Type: DRUG

Methotrexate

Administered along with HCT for Graft Versus Host Disease (GVHD) prophylaxis.

Intervention Type: DRUG

Other Intervention Names

PEGASYS®

Eligibility Criteria

Inclusion Criteria

• Patient must have AML not in remission or at very high risk for HCT (Hematopoietic Cell Transplantation) relapse.
• For newly diagnosed AML, patients must have achieved two consecutive induction attempts without achieving complete remission
• For patients initially in complete remission whose AML relapses > 6 months after preceding remission, one re-induction must be attempted to be eligible
• For AML patients with early relapse, in whom the preceding remission is shorter than 6 months duration, no re-induction regimen is necessary to be eligible
• Patients with antecedent MDS (Myelodysplastic Syndrome) who progress to AML may have therapies rendered during both phases counted towards these requirements.
• Patients with poor cytogenetic or molecular risk associated with very high risk for relapse after HCT may proceed without provisions for prior treatment. However, they must have received at least one induction attempt.
• Patients must be ≥ 18 years of age and considered a candidate for HCT
• Karnofsky ≥ 70% (Karnofsky performance status is measure of a cancer patients general well being and activities of daily life. Scores range from 100 to 0 where 100 is perfect health and 0 is death
• Patients must meet acceptable organ function criteria: Total Bilirubin ≤2.5 mg%; AST (Aspartate transaminase) and ALT (Alanine transaminase) <5.0 X institutional upper limit of normal; GFR (Glomerular filtration rate) >40 mL/min/1.73 m2 for patients with creatinine levels above institutional normal; Lung function tests (DLCO, FEV1, FVC) > 50%; Ejection fraction > 50%
• All patients must sign an informed consent
• Women and men of child-bearing potential must agree to use adequate contraception

Exclusion Criteria

• Prior chemotherapy treatment for AML within 21 days from the initiation of HCT conditioning
• Patients may NOT have evidence or symptoms of CNS disease at the time of enrollment
• HIV or HTLV1 / HTLV2 (Human T-lymphotrophic virus) (seropositivity and/or PCR positivity)
• Patients less than 18 years of age
• Pregnant and nursing mothers are excluded from this study
• Patients with untreated or uncontrolled neuropsychiatric illness
• Any physical or psychological condition that, in the opinion of the investigator, would pose unacceptable risk to the patient
• Uncontrolled infections

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan Rogel Cancer Center

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

John M Magenau, M.D.

Role: PRINCIPAL_INVESTIGATOR

University of Michigan Rogel Cancer Center

Locations

University of Michigan Comprehensive Cancer Center

Ann Arbor, Michigan, United States

Countries

United States

References

Magenau JM, Peltier D, Riwes M, Pawarode A, Parkin B, Braun T, Anand S, Ghosh M, Maciejewski J, Yanik G, Choi SW, Talpaz M, Reddy P. Type 1 interferon to prevent leukemia relapse after allogeneic transplantation. Blood Adv. 2021 Dec 14;5(23):5047-5056. doi: 10.1182/bloodadvances.2021004908.

Reference Type: DERIVED

PMID: 34607341 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

HUM00093471

Identifier Type: OTHER

Identifier Source: secondary_id

UMCC 2014.107

Identifier Type: -

Identifier Source: org_study_id