Neoplasms

Blood and Lymph Conditions

All Conditions

Hematologic Neoplasms

Hematologic Diseases

Anti-Infective Agents

All Drugs and Chemicals

Trichostatin A

Clotrimazole

Miconazole

Antifungal Agents

Enzyme Inhibitors

Histone Deacetylase Inhibitors

Vanda Pharmaceuticals

The aim of this study is to investigate the safety and tolerability of trichostatin A in individuals with relapsed or refractory hematologic malignancies.

Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies

Measured by spontaneous reporting of adverse events (AEs)

Symptoms and General Pathology

Immune System Diseases

Rare Diseases

Syndrome

Lymphoma

Leukemia

Preleukemia

Myelodysplastic Syndromes

Primary Myelofibrosis

Metaplasia

Bone Marrow Diseases

Myeloproliferative Disorders

Lymphosarcoma

Chronic Myeloproliferative Disorders

Antineoplastic Agents

Sirolimus

Temsirolimus

MTOR Inhibitors

Anti-Bacterial Agents

Antibiotics, Antitubercular

Immunosuppressive Agents

Immunologic Factors

AP23573 12.5 mg IV as monotherapy once daily for 5 days, every 2 weeks

ridaforolimus

Frank Haluska, M.D., Ph.D.

The purpose of this phase II study is to assess the efficacy of AP23573 in patients with specified relapsed or refractory hematological malignancies.

The primary objective of the trial is to assess the efficacy of AP23573 in patients with specified relapsed or refractory hematological malignancies by evaluating the response rates as defined for the individual malignancy categories. Secondary objectives include evaluating time to disease progression, progression-free survival and duration of response; evaluating the pharmacokinetic and pharmacodynamic characteristics of AP23573; describing health-related quality of life measurements; and exploring the safety and tolerability of AP23573 at the specified dose level.

Protocol Outline: Open label, non-randomized parallel cohorts of five disease-specific cohorts with a minimum of 21 patients per cohort. Each patient receives a fixed dose of AP23573 administered intravenously (IV) over 30 minutes daily for five days (QDx5) to be repeated every 2 weeks.

Study of AP23573 in Patients With Relapsed or Refractory Hematologic Malignancies (8669-024)(COMPLETED)

A Phase II Study of AP23573, an mTOR Inhibitor, in Patients With Relapsed or Refractory Hematologic Malignancies

Ariad Pharmaceuticals

Merck Sharp & Dohme LLC

Leukemia, Myeloid

Leukemia, Myeloid, Acute

Myeloid Leukemia

Acute Myeloid Leukemia

Acute Non Lymphoblastic Leukemia

Acute Graft Versus Host Disease

Venetoclax

Homoharringtonine

Omacetaxine 0.625 mg/m2 SQ injection q12h days 1-7 with Venetoclax 400 mg orally daily on days 4-28 Cycles are 28 days

Omacetaxine 1.25 mg/m2 SQ injection q12h days 1-7 with Venetoclax 400 mg orally daily on days 4-28 Cycles are 28 days

Omacetaxine 2.0 mg/m2 SQ injection q12h days 1-7 with Venetoclax 400 mg orally daily on days 4-28 Cycles are 28 days

Omacetaxine 2.5 mg/m2 SQ injection q12h days 1-7 with Venetoclax 400 mg orally daily on days 4-28 Cycles are 28 days

Escalating doses of Omacetaxine 0.625 mg/m2 q12h, 1.25 mg/m2 q12h, 2.0 mg/m2 q12h, and 2.5 mg/m2 q12h

Omacetaxine

John Quigley, MD

Kristen Kitsch, BS

John Qigley, MD

This will be a single arm, open label Phase Ib dose-escalation study of the combination of VEN and OM, conducted using an innovative Bayesian Optimal Interval-design, to find the MTD in participants with AML failing treatment with venetoclax-containing regimens. Treatment plan will consist of an induction phase, followed by a consolidation phase if applicable.

This is a Phase Ib study of VEN and OM, the investigator will conduct a Bayesian Optimal Interval-designed trial following the approach of Yuan et al 40 to find the MTD with a target DLT rate of 2%, 4 pre-specified doses, and between 24 and up to 30 participants. Beginning with the first participant treated at the lowest dose of OM 0.625 mg/m2 q12h with VEN 400 mg, dose escalation and de-escalation of OM will involve a comparison of the observed DLT rate (p) at the current dose with a pair of fixed, pre-specified boundary rates: λe (escalation) with p ≤ 0.157; λd (de-escalation) with p ≥ 0.238; or otherwise remain at the same dose per the dosing schedule. The trial will start with a cohort size of 1 participant (unless DLT is experienced) and escalated for each subsequent participant until the first DLT occurs and the current dose cohort is expanded to 3.40 In a simulation of these conditions with a target DLT rate of 20% (1), the percentage correct selection of the MTD is between 60% with enrollment of 20 participants and 70% with enrollment of 24 participants. Implementation of the trial design will be performed using R package 'BOIN'. If the investigator observes an unexpected toxicity in Cohort 1 the investigator will use OM 0.5 mg/m2 daily with VEN for Cohort -1 Following each cycle, participants will be evaluated for complete response (CR) by International Working Group (IWG) criteria 41

The subject visit schedule and procedures are below:

Screening Visit:

Physical Exam (vital signs, medical history, prior therapies, height and weight) Urine Pregnancy Test, EKG, Blood Work (Complete blood count, (CBC), basic metabolic panel (BMP), Uric Acid, Albumin, ALT/AST, bilirubin, alkaline phosphatase, protein, LDH, PT/INR, PTT and fibrinogen, HIV, Hepatitis B/C) Bone Marrow Aspirate

Treatment Visits:

Day 1 of Each Cycle:

Physical Exam Urine Pregnancy Test, EKG, (only after 1st, 7th and 11th dose of study medication) Blood Work (Complete blood count, (CBC), basic metabolic panel (BMP), Uric Acid, Albumin, ALT/AST, bilirubin, alkaline phosphatase, protein, LDH, PT/INR, PTT and fibrinogen, HIV, Hepatitis B/C) Study Drug (s) Given

Day 28 of each Cycle:

Bone Marrow Biopsy Safety Follow Up Visit: (14 days + 7 days after the last dose of treatment) performed 14 days (±7 days) after the last dose of treatment. Physical Exam, Blood Work (Complete blood count, (CBC), basic metabolic panel (BMP), Uric Acid, Albumin, ALT/AST, bilirubin, alkaline phosphatase, protein, LDH, PT/INR, PTT and fibrinogen, HIV, Hepatitis B/C) Long Term Follow Up Visit: (every 2 months ±14 days for 12 months), Physical Exam Blood Work (Complete blood count, (CBC), basic metabolic panel (BMP), Uric Acid, Albumin, ALT/AST, bilirubin, alkaline phosphatase, protein, LDH, PT/INR, PTT and fibrinogen, HIV, Hepatitis B/C)

Safety and Efficacy of Venetoclax With Escalating Doses of Omacetaxine in Patients With Acute Myeloid Leukemia Safety and Efficacy of Venetoclax With Escalating Doses of Omacetaxine in Patients With Acute Myeloid Leukemia (AML)

VEN-OM: Phase IB/II Study Of Safety And Efficacy Of Venetoclax When Combined With Escalating Doses Of Omacetaxine In Patients With AML Failing Treatment With Venetoclax-Containing Regimens

What is the MTD of Omacetaxine in combination with Venetoclax?

Number of participants achieving Overall Response Rate (ORR) after 3 cycles which includes Complete Response (CR) and Complete Remission with Incomplete hematologic recovery (CRi )

Number of participants having treatment related AES using CTCAE v5.0 criteria

Number of participants having OS measured from the date of entry to the date of death from any cause

Number of participants having EFS measured from the date of entry to the date of treatment failure, disease relapse, or death from any cause

University of Illinois at Chicago

Principal Investigator

Dose-finding stage: The dose escalation in this study is pre-defined in nine dose groups. The dose escalation starts with 0.01mg and proceeds from low to high doses.

Dose-expansion stage: Patients will be randomly assigned to receive different doses of SCTC21C at a ratio of 1:1. Doses of SCTC21C will be determined based on the data obtained in the Dose-finding stage.

SCTC21C is injected to the participants subcutaneously and is tentatively scheduled to be administered weekly for the first two cycles, once every 2weeks for cycle3-6, and once every 4 weeks thereafter until the occurrence of progressive disease

SCTC21C

Qiang Zhou

Wenming Chen

The purpose of this study is to evaluate the safety and efficacy of SCTC21C in patients with CD38+ hematologic malignancies

This is a multicenter, open-label, phase I study aimed to evaluate the safety, tolerability, pharmacokinetics（PK）, Pharmacodynamics（PD）, preliminary anti-tumor activity and immunogenicity of SCTC21C in patients with relapsed or refractory CD38+ hematologic malignancies.The study includes Dose-finding stage and Dose-expansion stage. In Dose-finding stage, participants will be assigned to receive sequentially higher doses of SCTC21C ranging from 0.01 to 960mg. In Dose-expansion stage, total of at least 20 participants will be randomly assigned to receive two different doses of SCTC21C at a ratio of 1:1.All participants will receive the treatment until disease progression or unacceptable drug-related adverse events.

A Clinical Study of SCTC21C in Participants With CD38+ Hematologic Malignancies

A Phase I Clinical Study Evaluating the Safety and Efficacy of SCTC21C in Participants With CD38+ Hematologic Malignancies

To identify the incidence of TEAEs and SAE

ORR is defined as the proportion of patients who have an objective remission

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies	NCT03838926	Relapsed or Ref...	Trichostatin A	18 Years -	Vanda Pharmaceuticals
Study of AP23573 in Patients With Relapsed or Refractory Hematologic Malignancies (8669-024)(COMPLETED)	NCT00086125	Hematologic Mal... Leukemia Myelodysplastic... Myeloid Metapla... Lymphoma	ridaforolimus	18 Years -	Merck Sharp & Dohme LLC
Study of AP23573 in Patients With Relapsed or Refractory Hematologic Malignancies (8669-024)(COMPLETED)	NCT00086125	Hematologic Mal... Leukemia Myelodysplastic... Myeloid Metapla... Lymphoma	ridaforolimus	18 Years -	Merck Sharp & Dohme LLC
Tolerability Study of Trichostatin A In Subjects With Relapsed or Refractory Hematologic Malignancies	NCT03838926	Relapsed or Ref...	Trichostatin A	18 Years -	Vanda Pharmaceuticals
Safety and Efficacy of Venetoclax With Escalating Doses of Omacetaxine in Patients With Acute Myeloid Leukemia Safety and Efficacy of Venetoclax With Escalating Doses of Omacetaxine in Patients With Acute Myeloid Leukemia (AML)	NCT04926285	Relapsed or Ref...	Omacetaxine Venetoclax	18 Years - 75 Years	University of Illinois at Chicago
A Clinical Study of SCTC21C in Participants With CD38+ Hematologic Malignancies	NCT06252298	Relapsed or Ref...	SCTC21C	18 Years -	Sinocelltech Ltd.

Spots Global Cancer Trial Database for relapsed or refractory hematologic malignancies