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HMA

Phase 1

Acute Myelogenous Leukemia | Small molecule | Oncology |Pfizer, Inc.|Last Updated: Jan 5, 2018

Success Probability

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Market & Valuation

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Trial Design

CONTROLLED
Total Trials1
Total Enrollment195

FDA Designations

No designations recorded

Clinical trial landscape

HMA · 1 trial · 3 indications

Phase 1 1
NCT01902329A Safety Study of SGN-CD33A in AML PatientsAcute Myelogenous Leukemia
COMPLETED195 Analytics
PHASE1COMPLETED
A Safety Study of SGN-CD33A in AML Patients
Acute Myelogenous LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of adverse events
Through 1 month following last dose
Incidence of laboratory abnormalities
Through 1 month following last dose

Secondary Endpoints

Blood concentrations of SGN-CD33A and metabolites
Through 3 weeks after dosing
Incidence of antitherapeutic antibodies
Through 1 month following last dose
Rate of complete remission
Up to 3 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
SGN-CD33A + HMAEXPERIMENTALSGN-CD33A with hypomethylating agent
SGN-CD33A MonotherapyEXPERIMENTALSGN-CD33A

Interventions

NameTypeDescription
HMADRUGazacitidine 75 mg/m2 for 7 days or decitabine 20mg/m2 for 5 days
SGN-CD33ADRUGGiven intravenously on Day 1 or Days 1 and 4 every 3 weeks (SGN-CD33A Monotherapy) or given intravenously on the final HMA dosing day every 4 weeks (SGN-CD33A+HMA)
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites14

Inclusion Criteria: * Acute myeloid leukemia, positive for CD33 * Eastern Cooperative Oncology Group status of 0 or 1 * Adequate baseline renal and hepatic function * Central venous access * Either achieved complete remission (greater than 12 weeks in duration) with initial induction/consolidation ...

Countries:United States
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Frequently asked questions about HMA

What is HMA used for in Acute Myelogenous Leukemia?

HMA is an investigational small molecule being studied for the treatment of Acute Myelogenous Leukemia (AML). It is currently in Phase 1 clinical development. The drug is being evaluated in patients with AML, including related conditions such as Acute Myeloid Leukemia and Acute Promyelocytic Leukemia.

Who makes HMA?

HMA is being developed by Pfizer, Inc., a biopharmaceutical company traded on the New York Stock Exchange under the ticker symbol PFE. The drug is currently in Phase 1 clinical development for the treatment of Acute Myelogenous Leukemia.

What phase is HMA in?

HMA is in Phase 1 clinical development. It is an investigational drug being studied for the treatment of Acute Myelogenous Leukemia. The drug has completed one Phase 1 clinical trial and is not yet approved by regulatory authorities.

What clinical trials is HMA in?

HMA has been studied in one completed Phase 1 clinical trial with the identifier NCT01902329. This trial, titled 'A Safety Study of SGN-CD33A in AML Patients', enrolled 195 participants with Acute Myelogenous Leukemia, Acute Myeloid Leukemia, and Acute Promyelocytic Leukemia. The trial was conducted in the United States.

Is HMA FDA approved?

HMA is not FDA approved. It is an investigational drug currently in Phase 1 clinical development for the treatment of Acute Myelogenous Leukemia. The drug has completed one Phase 1 clinical trial, but it has not yet received regulatory approval.