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Clinical Trial of BP1001 in Combination With With Venetoclax Plus Decitabine in AML

ConditionAcute Myeloid Leukemia (AML)
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorBio-Path Holdings, Inc.

About this trial

The primary objectives of this study are to assess: (1) whether the combination of BP1001 plus venetoclax plus decitabine provides greater efficacy (Complete Remission \[CR\], Complete Remission with incomplete hematologic recovery \[CRi\], Complete Remission with partial hematologic recovery \[CRh\], than venetoclax plus decitabine alone (by historical comparison) in participants with untreated AML that cannot or elect not to be treated with more intensive chemotherapy; (2) whether BP1001-based treatment provides greater efficacy (CR, CRi, CRh) than intensive chemotherapy (by historical comparison) in participants with refractory/relapsed AML.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Adults ≥18 years of age

Females must be of non-childbearing potential, surgically sterile, postmenopausal, or practice adequate methods of contraception during the study and for 30 days after the last dose of study drug or decitabine

Males must agree to use an adequate method of contraception during the study and for at least 30 days after the last dose of study drug or decitabine

Newly diagnosed untreated AML; or

Disqualifiers

Active non-hematologic or lymphoid malignancy other than AML treated with immuno- or chemotherapy within the previous 12 months except active non- melanoma, non-invasive skin cancer will be allowed.

Known, active leptomeningeal leukemia requiring intrathecal therapy. NOTE: Patients with a history of CNS disease may be allowed to participate based on at least 1 documented, negative spinal fluid assessment within 28 days prior to Screening

Isolated extramedullary leukemia without also meeting bone marrow criteria for acute leukemia (for AML usually = 20% blasts in BMA or BMB). Patients may have leukemia with lower blast counts (Dohner et al. 2010). Bio-Path Holdings and Investigator concurrence required.

Acute promyelocytic leukemia (APL) with t(15;17)(q22;q12) PML-RARA

Trial design

Design model

Parallel

Treatments tested in this trial

  • BP1001 in combination with Ventoclax plus decitabine

    Drug

    BP1001 in combination with Ventoclax plus decitabine

  • BP1001 plus decitabine

    Drug

    BP1001 plus decitabine in ventoclax intolerant or resistant subjects

Treatment groups

108 Participants
are divided into 3 treatment groups
Group A: Untreated AMLExperimental treatment 1 intervention
Group B: Refractory/Relapsed AMLExperimental treatment 1 intervention
Group C: Refractory/Relapsed AML (ventoclax-intolerant or resistant)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Assessment of efficacy in untreated AML subjects by bone marrow aspirate or biopsy

Assess whether the combination of BP1001 and Ventoclax plus decitabine provides greater efficacy (Complete Remission \[CR\], Complete Remission with incomplete hematologic recovery \[CRi\], Complete Remission with partial hematologic recovery \[CRh\], than Ventoclax + decitabine alone (by historical comparison) with untreated AML that cannot or elect not to be treated with more intensive chemotherapy

Time frame
180 days
2

Assessment of efficacy in refractory/relapsed AML subjects by bone marrow aspirate or biopsy

Assess whether BP1001-based treatment provides greater efficacy (CR, CRi, CRh) than intensive chemotherapy (by historical comparison) in participants with refractory/relapsed AML.

Time frame
180 days

Secondary outcomes

1

Assessment of safety of BP1001 in combination with Ventoclax plus decitabine

Evaluate safety and toxicity of the combination of BP1001 with Ventoclax plus decitabine using non-hematologic and hematologic measures per NCI CTCAE criteria (with a safety run-in)

Time frame
30 days
2

Assessment of the pharmacokinetics (PK) of BP1001 when given in combination with Ventoclax plus decitabine

Evaluate the in vivo PK using plasma to compute half life and elimination.

Time frame
30 days
3

Assessment of Minimal Residual Disease (MRD) status in patients who achieve CR/CRi/CRh with BP1001-based treatment

Assess time to response from administration of BP1001-based treatment to CR, CRi, or CRh, negative MRD status as defined by the site and as available (Usually ≤ 0.1% by multi-parameter flow cytometry).

Time frame
30 days
4

Assessment of Partial Remissions and blast count reductions.

Assessment of Partial Remissions (per Cheson, 2003), and blast count reductions (per Williams, 2016)

Time frame
30 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Bio-Path Holdings, Inc.

Lead sponsor

Source ClinicalTrials.gov
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