Back to results

Immunochemotherapy and AlloSCT in Patients With High Risk CD33+ AML/MDS

Primary Purpose

Acute Myelogenous Leukemia, Myelodysplastic Syndrome

Status

Active

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Gemtuzumab Ozogamicin

About this trial

This is an interventional treatment trial for Acute Myelogenous Leukemia focused on measuring targeted therapy, leukemia, MDS, immune therapy

Eligibility Criteria

undefined - 25 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Disease Status:
- History of AML Induction/Reinduction Failure
- AML 1st Complete Remission (CR) with poor cytogenetics
- AML 2nd CR with minimal residual disease (MRD)
- AML 3rd CR
- AML in refractory relapse but ≤25% bone marrow leukemia blasts
- MDS with >6% bone marrow blasts at diagnosis
- Secondary MDS with ≤5% bone marrow myeloblasts at diagnosis

Disease Immunophenotype:

• Disease must express a minimum of >/= 10% CD33+ for patients with AML

Organ Function:

• Adequate renal function, adequate liver function, adequate cardiac function, adequate pulmonary function Age: ≤25 years of age Donor: matched family donor, unrelated cord blood donor, unrelated adult donor

Exclusion Criteria:

Patients with active central nervous system (CNS) AML/MDS disease at time of conditioning therapy
Female patients who are pregnant
Karnofsky <50% or Lansky <50% if 10 years or less
Age >25 years
Has received gemtuzumab in the previous 30 days or has not recovered from prior gemtuzumab therapy.

Sites / Locations

New York Medical College

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Gemtuzumab Ozogamicin

Arm Description

Conditioning therapy with Gemtuzumab Ozogamicin in combination with busulfan and cyclophosphamide chemotherapy followed by allogeneic stem cell transplantation.

Outcomes

Primary Outcome Measures

Response rate

overall response rate (CR + PR) in patients receiving GO, busulfan and cyclophosphamide and AlloSCT in patients with measurable disease (relapse/refractory) with high risk CD33+ AML/MDS

Secondary Outcome Measures

Full Information

NCT ID

NCT02221310

First Posted

July 31, 2014

Last Updated

September 26, 2022

Sponsor

New York Medical College

1. Study Identification

Unique Protocol Identification Number

NCT02221310

Brief Title

Immunochemotherapy and AlloSCT in Patients With High Risk CD33+ AML/MDS

Official Title

A Pilot Study of Gemtuzumab Ozogamicin in Combination With Busulfan and Cyclophosphamide (Immunochemotherapy) and Allogeneic Stem Cell Transplantation in Patients With High Risk Acute Myelogenous Leukemia and Myelodysplastic Syndrome

Study Type

Interventional

2. Study Status

Record Verification Date

September 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

November 2011 (undefined)

Primary Completion Date

June 2023 (Anticipated)

Study Completion Date

June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

New York Medical College

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

Targeted immune therapy with gemtuzumab ozogamicin (Mylotarg) in combination with chemotherapy followed by allogeneic stem cell transplantation will be given to patients with high risk acute myelogenous leukemia (AML) or myelodysplastic syndrome (MDS).

Detailed Description

Gemtuzumab ozogamicin in combination with busulfan and cyclophosphamide (immunochemotherapy) conditioning followed by allogeneic stem cell transplantation + anti-thymocyte globulin (unrelated donors only) in patients with high risk CD33+AML or MDS meeting eligibility criteria.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Myelogenous Leukemia, Myelodysplastic Syndrome

Keywords

targeted therapy, leukemia, MDS, immune therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

25 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Gemtuzumab Ozogamicin

Arm Type

Experimental

Arm Description

Conditioning therapy with Gemtuzumab Ozogamicin in combination with busulfan and cyclophosphamide chemotherapy followed by allogeneic stem cell transplantation.

Intervention Type

Drug

Intervention Name(s)

Gemtuzumab Ozogamicin

Other Intervention Name(s)

Mylotarg

Intervention Description

Gemtuzumab Ozogamicin 7.5 mg/m^2/dose given IV over 2 hours once during conditioning

Primary Outcome Measure Information:

Title

Response rate

Description

overall response rate (CR + PR) in patients receiving GO, busulfan and cyclophosphamide and AlloSCT in patients with measurable disease (relapse/refractory) with high risk CD33+ AML/MDS

Time Frame

1 year

10. Eligibility

Sex

All

Maximum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Disease Status: History of AML Induction/Reinduction Failure AML 1st Complete Remission (CR) with poor cytogenetics AML 2nd CR with minimal residual disease (MRD) AML 3rd CR AML in refractory relapse but ≤25% bone marrow leukemia blasts MDS with >6% bone marrow blasts at diagnosis Secondary MDS with ≤5% bone marrow myeloblasts at diagnosis Disease Immunophenotype: • Disease must express a minimum of >/= 10% CD33+ for patients with AML Organ Function: • Adequate renal function, adequate liver function, adequate cardiac function, adequate pulmonary function Age: ≤25 years of age Donor: matched family donor, unrelated cord blood donor, unrelated adult donor Exclusion Criteria: Patients with active central nervous system (CNS) AML/MDS disease at time of conditioning therapy Female patients who are pregnant Karnofsky <50% or Lansky <50% if 10 years or less Age >25 years Has received gemtuzumab in the previous 30 days or has not recovered from prior gemtuzumab therapy.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mitchell S Cairo, MD

Organizational Affiliation

New York Medical College

Official's Role

Principal Investigator

Facility Information:

Facility Name

New York Medical College

City

Valhalla

State/Province

New York

ZIP/Postal Code

10595

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Citations:

PubMed Identifier

22079471

Citation

Satwani P, Bhatia M, Garvin JH Jr, George D, Dela Cruz F, Le Gall J, Jin Z, Schwartz J, Duffy D, van de Ven C, Foley S, Hawks R, Morris E, Baxter-Lowe LA, Cairo MS. A Phase I study of gemtuzumab ozogamicin (GO) in combination with busulfan and cyclophosphamide (Bu/Cy) and allogeneic stem cell transplantation in children with poor-risk CD33+ AML: a new targeted immunochemotherapy myeloablative conditioning (MAC) regimen. Biol Blood Marrow Transplant. 2012 Feb;18(2):324-9. doi: 10.1016/j.bbmt.2011.11.007. Epub 2011 Nov 9.

Results Reference

background

Learn more about this trial

Immunochemotherapy and AlloSCT in Patients With High Risk CD33+ AML/MDS

We'll reach out to this number within 24 hrs