A Phase 1/2 Study in Patients with Relapsed or Refractory Acute Myeloid Leukemia or Intermediate-2/High Risk Myelodysplastic Syndrome

Phase 1

• Conditions: Relapsed or Refractory Acute Myeloid Leukemia or Intermediate-2/High Risk Myelodysplastic Syndrome; MedDRA version: 21.0Level: LLTClassification code 10000886Term: Acute myeloid leukemiaSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); MedDRA version: 21.1Level: PTClassification code 10028533Term: Myelodysplastic syndromeSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps); Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]

• Registration Number: EUCTR2015-003813-11-DE
• Lead Sponsor: MacroGenics, Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-12-29
• Last Update Posted: 14 March 2022

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 330

Inclusion Criteria

1. Patients must have a confirmed diagnosis of primary or secondary AML (any subtype except APL) according to World Health Organization (WHO) classification.
2. Patients with AML must meet one of the following criteria:
a. Primary Induction Failure (PIF) AML, defined as disease refractory to one of the following, i or ii:
i. An intensive induction attempt, per institution. Induction attempts include high-dose and/or standard-dose cytarabine ± an anthracyclines/anthracenedione ± an anti-metabolite, with or without growth factor or targeted therapy containing regimens.
Examples include but are not limited to:
1. One cycle of high dose cytarabine (HiDAC) containing regimen
2. One cycle of liposomal cytarabine and daunorubicin
3. Two cycles of standard dose cytarabine containing regimen
ii. For adults who are age 75 years or older, or who have comorbidities that preclude use of intensive induction chemotherapy; PIF is defined as AML refractory to one of the following less intensive regimens, 1 or 2:
1. = 2 but = 4 cycles of Bcl-2 inhibitors in combination with azacitidine, decitabine, or low dose cytarabine
2. = 2 but = 4 cycles of gemtuzumab ozogamicin monotherapy
b. Early relapse (ER) AML, defined as AML in first relapse with initial CR1 duration < 6 months
3. Limit of 3 prior lines of therapy (excluding focal radiation therapy for
palliative purposes): up to 2 induction (induction, reinduction) or 1 induction plus/minus 1 consolidation attempt, followed by a maximum of 1 salvage/re-induction attempt
4. Eastern Cooperative Oncology Group (ECOG) performance status < or = 2.
5. Life expectancy of at least 4 weeks.
6. Peripheral blast count < or = 20,000/mm3 at the time of registration
(see related Exclusion Criterion 3).
7. Acceptable laboratory parameters and adequate organ reserve
8. Adult: Eighteen (18) years of age or older
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 180

Exclusion Criteria

1. Prior history of allogeneic stem cell transplantation
2. Prior treatment with an anti-CD123-directed agent, with the exclusion of patients with relapsed disease after MGD006 treatment.
3. Need for concurrent other cytoreductive chemotherapy
4. Any active untreated autoimmune disorders (with the exception of vitiligo, resolved childhood atopic dermatitis, prior Grave's disease now euthyroid clinically and with stable supplementation)
5. Second primary malignancy that requires active therapy. Adjuvant hormonal therapy is allowed.
6. Antitumor therapy (chemotherapy, radiotherapy, antibody therapy, moleculartargeted therapy, retinoid therapy, or investigational agent) within 14 days or 5 half-lives of Cycle 1 Day 1.
7. Requirement, at the time of study entry, for concurrent steroids > 10 mg/day of oral prednisone or the equivalent, except steroid inhaler, otic preparations, nasal spray or ophthalmic solution.
8. Use of immunosuppressant medications (other than steroids as noted) in the 2 weeks prior to study drug administration (Cycle 1 Day 1).
9. Use of granulocyte colony stimulating or granulocyte-macrophage colony stimulating factor in the 2 weeks prior to study drug administration (Cycle 1 Day 1).
10. Known central nervous system (CNS) leukemia.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified