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NCT01998035 · REGISTRY CONDITION SEARCH

Romidepsin Plus Oral 5-Azacitidine in Relapsed/Refractory Lymphoid Malignancies

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase
PHASE1, PHASE2
Status at capture
TERMINATED
Registry last update
2024-08-22

This is an open label, phase I/IIa, 3 x 3 dose escalation study with an initial phase I followed by a disease focused phase II. The primary objective of the phase I is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romidepsin in patients with lymphoma. The safety and toxicity of this combination will be evaluated throughout the entire study. If the combination of oral 5-azacitidine and romidepsin is found to be feasible and an MTD is established, the phase II part of the study will be initiated. Phase II will consist of a 2 stage design of the combination of oral 5-azacitidine and romidepsin for patients with relapsed or refractory T-cell lymphomas.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Phase I: Maximum Tolerated Dose (MTD) of the Combination of Oral 5-azacitidine in Combination With Romidepsin

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outcome · POSTED

Phase I: Maximum Tolerated Dose (MTD) of Romidepsin in Combination With Oral 5-azacytidine

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outcome · POSTED

Percentage of Patients Who Experienced Significant Toxicities in Phase 1

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outcome · POSTED

Phase II: Overall Response Rate (ORR) (Complete + Partial Response) of the Combination of Oral 5-azacitidine and Romidepsin in Patients With Relapsed/Refractory T-Cell Lymphoma

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part
eligibility Criteria
Inclusion Criteria: * Phase I: Histologically confirmed relapsed or refractory non-Hodgkin lymphoma or Hodgkin lymphoma (WHO criteria), with no accepted curative options. * Phase II: Relapsed or refractory T-cell lymphoma, including patients with central nervous system (CNS) involvement or lymphomatous meningitis are allowed on study. * Relapsed or refractory disease following frontline chemotherapy. No upper limit for the number of prior therapies. Patients may have relapsed after prior autologous or allogeneic stem cell transplant. * Evaluable Disease in the Phase I, and measurable disease for the Phase II. * Age \> or = 18 years. * Eastern Cooperative Oncology Group (ECOG) performance status \< or = 2. * Patients must have adequate organ and marrow function. * Negative urine or serum pregnancy test for females of childbearing potential. * All females of childbearing potential must use an effective barrier method of contraception during the treatment period and for at least 1 month thereafter. Male subjects should use a barrier method of contraception during the treatment period and for at least 3 months thereafter. * Ability to understand and the willingness to sign a written informed consent document. Exclusion Criteria: * Prior Therapy * Exposure to chemotherapy or radiotherapy within 2 weeks prior to entering the study or those who have not recovered from adverse events due to agents administered more than 2 weeks earlier. * Systemic steroids that have not been stabilized ( ≥ 5 days) to the equivalent of ≤10 mg/day prednisone prior to the start of the study drugs. * No other concurrent investigational agents are allowed. * History of allergic reactions to Oral 5-azacitidine or Romidepsin. * Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements. * Pregnant women. * Nursing women. * Active concurrent malignancy (except non-melanoma skin cancer or carcinoma in situ of the cervix). If there is a history of prior malignancy, the patient must be disease-free for ≥ 3 years. * Patients known to be Human Immunodeficiency Virus (HIV)-positive. * Patients with active hepatitis A, hepatitis B, or hepatitis C infection. * Concomitant use of CYP3A4 inhibitors. * Any known cardiac abnormalities.
healthy Volunteers
false
minimum Age
18 Years
sex
ALL
std Ages
  1. ADULT
  2. OLDER_ADULT
Treatment arms and interventions
arm Groups
  1. description
    Oral 5-Azacitidine 100 mg (Days 1-14) Romidepsin (10 mg/m2, Day 8), cycle length (28 days)
    intervention Names
    1. Drug: RomiDEPsin 10 MG/M2
    2. Drug: Oral 5-Azacitidine 100 MG
    label
    R/O: Level -1
    type
    EXPERIMENTAL
  2. description
    Oral 5-Azacitidine 100 mg (Days 1-14) Romidepsin (10 mg/m2, Days 8 and 15), cycle length (28 days)
    intervention Names
    1. Drug: RomiDEPsin 10 MG/M2
    2. Drug: Oral 5-Azacitidine 100 MG
    label
    R/O: Level 1
    type
    EXPERIMENTAL
  3. description
    Oral 5-Azacitidine 200 mg (Days 1-14) Romidepsin (10 mg/m2, Days 8 and 15), cycle length (28 days)
    intervention Names
    1. Drug: RomiDEPsin 10 MG/M2
    2. Drug: Oral 5-Azacitidine 200 MG
    label
    R/O: Level 2
    type
    EXPERIMENTAL
  4. description
    Oral 5-Azacitidine 300 mg (Days 1-14) Romidepsin (10 mg/m2, Days 8 and 15), cycle length (28 days)
    intervention Names
    1. Drug: RomiDEPsin 10 MG/M2
    2. Drug: Oral 5-Azacitidine 300 MG
    label
    R/O: Level 3
    type
    EXPERIMENTAL
  5. description
    Oral 5-Azacitidine 300 mg (Days 1-14) Romidepsin (14 mg/m2, Days 8 and 15), cycle length (28 days)
    intervention Names
    1. Drug: Romidepsin 14 MG/M2
    2. Drug: Oral 5-Azacitidine 300 MG
    label
    R/O: Level 4
    type
    EXPERIMENTAL
  6. description
    Oral 5-Azacitidine 300 mg (Days 1-14) Romidepsin (14 mg/m2, Days 8, 15 and 22), cycle length (35 days)
    intervention Names
    1. Drug: Romidepsin 14 MG/M2
    2. Drug: Oral 5-Azacitidine 300 MG
    label
    R/O: Level 5
    type
    EXPERIMENTAL
  7. description
    Oral 5-Azacitidine 300 mg (Days 1-21) Romidepsin (14 mg/m2, Days 8, 15 and 22), cycle length (35 days)
    intervention Names
    1. Drug: Romidepsin 14 MG/M2
    2. Drug: Oral 5-Azacitidine 300 MG
    label
    R/O: Level 6
    type
    EXPERIMENTAL
interventions
  1. arm Group Labels
    1. R/O: Level -1
    2. R/O: Level 1
    3. R/O: Level 2
    4. R/O: Level 3
    description
    Romidepsin is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Romidepsin is classified as a "Histone Deacetylase Inhibitor". Dose escalation (10 mg/m2)
    name
    RomiDEPsin 10 MG/M2
    other Names
    1. Istodax
    type
    DRUG
  2. arm Group Labels
    1. R/O: Level -1
    2. R/O: Level 1
    description
    A pyrimidine nucleoside analogue of cytidine with antineoplastic activity. Dose escalation (100 mg)
    name
    Oral 5-Azacitidine 100 MG
    other Names
    1. 5-AC
    type
    DRUG
  3. arm Group Labels
    1. R/O: Level 4
    2. R/O: Level 5
    3. R/O: Level 6
    description
    Romidepsin is an anti-cancer ("antineoplastic" or "cytotoxic") chemotherapy drug. Romidepsin is classified as a "Histone Deacetylase Inhibitor". Dose escalation (14 mg/m2)
    name
    Romidepsin 14 MG/M2
    other Names
    1. Istodax
    type
    DRUG
  4. arm Group Labels
    1. R/O: Level 2
    description
    A pyrimidine nucleoside analogue of cytidine with antineoplastic activity. Dose escalation (200 mg)
    name
    Oral 5-Azacitidine 200 MG
    other Names
    1. 5-AC
    type
    DRUG
  5. arm Group Labels
    1. R/O: Level 3
    2. R/O: Level 4
    3. R/O: Level 5
    4. R/O: Level 6
    description
    A pyrimidine nucleoside analogue of cytidine with antineoplastic activity. Dose escalation (300 mg)
    name
    Oral 5-Azacitidine 300 MG
    other Names
    1. 5-AC
    type
    DRUG
Study design
allocation
NON_RANDOMIZED
intervention Model
SEQUENTIAL
masking Info
masking
NONE
primary Purpose
TREATMENT
Enrollment
count
58
type
ACTUAL
Registered outcome plans (not posted results)
primary Outcomes
  1. description
    The highest dose of a drug or treatment that does not cause unacceptable side effects. The MTD is determined in clinical trials by testing increasing doses on different groups of people until the highest dose with acceptable side effects is found.
    measure
    Phase I: Maximum Tolerated Dose (MTD) of the Combination of Oral 5-azacitidine in Combination With Romidepsin
    time Frame
    up to 1.5 years
  2. description
    The highest dose of a drug or treatment that does not cause unacceptable side effects. The MTD is determined in clinical trials by testing increasing doses on different groups of people until the highest dose with acceptable side effects is found.
    measure
    Phase I: Maximum Tolerated Dose (MTD) of Romidepsin in Combination With Oral 5-azacytidine
    time Frame
    up to 1.5 years
  3. description
    Patients receiving the combination of oral 5-azacitidine and romidepsin and experiencing grades 1-4 toxicities will be tallied based on events observed and assessed by a qualified investigator. This Outcome Measure is specifically for Phase 1 of the study.
    measure
    Percentage of Patients Who Experienced Significant Toxicities in Phase 1
    time Frame
    Up to 1.5 years
  4. description
    The percentage of people in a study or treatment group who have a partial response or complete response to the treatment within a certain period of time. A partial response is a decrease in the size of a tumor or in the amount of cancer in the body, and a complete response is the disappearance of all signs of cancer in the body. In a clinical trial, measuring the ORR is one way to see how well a new treatment works.
    measure
    Phase II: Overall Response Rate (ORR) (Complete + Partial Response) of the Combination of Oral 5-azacitidine and Romidepsin in Patients With Relapsed/Refractory T-Cell Lymphoma
    time Frame
    Up to 3 years
Full study description
brief Summary
This is an open label, phase I/IIa, 3 x 3 dose escalation study with an initial phase I followed by a disease focused phase II. The primary objective of the phase I is to determine the maximum tolerated dose (MTD) and dose limiting toxicity (DLT) of the combinations of oral 5-azacitidine and romidepsin in patients with lymphoma. The safety and toxicity of this combination will be evaluated throughout the entire study. If the combination of oral 5-azacitidine and romidepsin is found to be feasible and an MTD is established, the phase II part of the study will be initiated. Phase II will consist of a 2 stage design of the combination of oral 5-azacitidine and romidepsin for patients with relapsed or refractory T-cell lymphomas.
detailed Description
Subjects will receive oral 5-azacitidine and romidepsin, administered as follows: oral 5-azacitidine from Days 1-14 (Dose cohorts -1 to 5) or Days 1-21 (Dose cohort 6); and romidepsin administered intravenously on Days 8 (Dose cohorts 1-4) of a 28 day cycle, and Day 22 (Dose cohorts 5 and 6) of a 35 day cycle. Cohorts of 3 patients will be enrolled sequentially as outlined in the dose escalation scheme. Once the MTD is reached the Phase II part of the protocol will be initiated in patients with T-Cell Lymphoma.
Source references
references
  1. citation
    Falchi L, Ma H, Klein S, Lue JK, Montanari F, Marchi E, Deng C, Kim HA, Rada A, Jacob AT, Kinahan C, Francescone MM, Soderquist CR, Park DC, Bhagat G, Nandakumar R, Menezes D, Scotto L, Sokol L, Shustov AR, O'Connor OA. Combined oral 5-azacytidine and romidepsin are highly effective in patients with PTCL: a multicenter phase 2 study. Blood. 2021 Apr 22;137(16):2161-2170. doi: 10.1182/blood.2020009004.
    pmid
    33171487
    type
    DERIVED
  2. citation
    O'Connor OA, Falchi L, Lue JK, Marchi E, Kinahan C, Sawas A, Deng C, Montanari F, Amengual JE, Kim HA, Rada AM, Khan K, Jacob AT, Malanga M, Francescone MM, Nandakumar R, Soderquist CR, Park DC, Bhagat G, Cheng B, Risueno A, Menezes D, Shustov AR, Sokol L, Scotto L. Oral 5-azacytidine and romidepsin exhibit marked activity in patients with PTCL: a multicenter phase 1 study. Blood. 2019 Oct 24;134(17):1395-1405. doi: 10.1182/blood.2019001285.
    pmid
    31471376
    type
    DERIVED
Source notices and limitations
    Discovery and provenance
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    Preserved source evidence · Not medical advice