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Trial record 18 of 390 for:    Lymphoma AND (women OR woman OR female)

Cyclophosphamide and Alemtuzumab In Lymphoma

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ClinicalTrials.gov Identifier: NCT03132584
Recruitment Status : Recruiting
First Posted : April 28, 2017
Last Update Posted : September 18, 2017
Sponsor:
Collaborators:
Genzyme, a Sanofi Company
Sanofi
Information provided by (Responsible Party):
Ann S. LaCasce, MD, Dana-Farber Cancer Institute

Brief Summary:

This research study is studying a combination of chemotherapy drugs as a possible treatment for aggressive lymphoma that has not responded to standard treatment.

The names of the study interventions involved in this study are:

  • Cyclophosphamide
  • Alemtuzumab

Condition or disease Intervention/treatment Phase
Non Hodgkin Lymphoma High-grade B-cell Lymphoma CD52 Positive Non-Hodgkin Lymphoma DLBCL or High-grade B-cell Lymphoma NOS Drug: Cyclophosphamide Drug: Alemtuzumab Phase 1

Detailed Description:

This research study is a Phase I clinical trial, which tests the safety of an investigational intervention and also tries to define the appropriate dose of the investigational intervention to use for further studies. "Investigational" means that the intervention is being studied.

The FDA (the U.S. Food and Drug Administration) has not approved alemtuzumab for aggressive lymphoma but it has been approved for other uses.

In this research study, the investigators are studying the combination of cyclophosphamide and alemtuzumab in participants with several types of aggressive lymphoma which are positive for a protein called CD52, the target of alemtuzumab. Studies in laboratory models of CD52 positive lymphoma showed the combination of cyclophosphamide and alemtuzumab was very effective. Cyclophosphamide causes a specific type of immune cell, called a macrophage, to attack lymphoma cells treated with alemtuzumab. Both drugs have been used in participants with lymphoma but have not been previously combined in this way. The investigators hope to identify the highest dose of the drugs that can be safely given together and to see if the combination if effective in treating these lymphomas.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Intervention Model: Single Group Assignment
Intervention Model Description: This is a phase I study in the standard 3+3 dose escalation design
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 1 Study of Cyclophosphamide and Alemtuzumab in CD52 Positive Relapsed/Refractory Double-Hit Lymphoma, Diffuse Large B-cell Lymphoma or High Grade B-cell Lymphoma, NOS With MYC and BCL-2 Over-expression, MYC-Positive Transformed Follicular Lymphoma, and CD52 Positive Mature T-cell Lymphoproliferative Disorder
Actual Study Start Date : July 30, 2017
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : May 1, 2023


Arm Intervention/treatment
Experimental: Cyclophosphamide and Alemtuzumab

After the screening procedures confirm participation in the research study:

The investigators are looking for the highest dose of the combination of study drugs that can be administered safely without severe or unmanageable side effects in participants that have CD52 positive aggressive lymphoma. Not everyone who participates in this research study will receive the same dose of the study drug. The dose given will depend on the number of participants who have been enrolled in the study prior and how well the dose was tolerated.

  • Cyclophosphamide
  • Alemtuzumab
Drug: Cyclophosphamide

The chemotherapy drugs will be given in the hospital. During the first cycle of treatment, participants will stay in the hospital until their blood counts have recovered after treatment. During cycles 2 and 3, participants may go home after chemotherapy if they are doing well. The length of each cycle is 28 days

- Via IV Day 3

Other Names:
  • Endoxan
  • Cytoxan
  • Lyophilized Cytoxan
  • Neosar
  • Revimmune
  • Procytox
  • Cycloblastin

Drug: Alemtuzumab
  • The chemotherapy drugs will be given in the hospital. During the first cycle of treatment, participants will stay in the hospital until their blood counts have recovered after treatment. During cycles 2 and 3, participants may go home after chemotherapy if they are doing well. The length of each cycle is 28 days
  • Alemtuzumab will be administered as follows:

    • IV Day 1
    • IV Day 2
    • Target dose IV on Day 3 and 4
Other Name: Campath




Primary Outcome Measures :
  1. MTD of Cyclophosphamide and Alemtuzumab [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Overall Response Rate [ Time Frame: 12 Months ]
    Non-Hodgkin Lymphoma Response Criteria, which will be reported descriptively

  2. Complete Response Rate [ Time Frame: 12 Months ]
    Non-Hodgkin Lymphoma Response Criteria, which will be reported descriptively

  3. Progression Free Survival [ Time Frame: up to 5 years ]
    Progression-free will be estimated using the method of Kaplan and Meier.

  4. Overall Survival [ Time Frame: up to 5 years ]
    Overall survival will be estimated using the method of Kaplan and Meier.

  5. Response Rate [ Time Frame: 28 Days ]
    Assess response by PET/CT and in the bone marrow after one cycle of therapy



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participants must have histologically confirmed non-Hodgkin lymphoma and be considered ineligible for standard curative therapeutic options, including high dose chemotherapy with autologous stem cell rescue.
  • Participants with the following subtypes of CD52 positive non-Hodgkin lymphoma (defined as ≥ 50% positive staining by immunohistochemical staining or flow cytometry by local lab) will be considered eligible:
  • High-grade B-cell lymphoma, with MYC and BCL2 and/or BCL6 rearrangements (DHL)
  • DLBCL or high-grade B-cell lymphoma NOS or B-cell lymphoma unclassifiable with features intermediate between Burkitt lymphoma and diffuse large B-cell lymphoma with MYC and BCL2 protein over-expression by immunohistochemical (IHC) staining as defined by MYC expression in ≥ 40% of cells and BCL2 positivity ≥ 50% (DOL)
  • Transformed lymphoma with MYC rearrangement by FISH or over-expression by IHC, as above
  • CD52 positive mature T-cell lymphoproliferative disorder
  • There is no limit to the prior number of chemotherapy regimens. Patients with prior autologous or allogeneic stem cell transplantation, as well as prior therapy with cyclophosphamide or alemtuzumab, are eligible.
  • Age ≥ 18 and ≤75
  • ECOG performance status ≤2 (Karnofsky ≥60%, see Appendix A)
  • Participants must have normal organ and marrow function as defined by peripheral blood values below:

    • leukocytes ≥1,000/mcL
    • absolute neutrophil count ≥500/mcL
    • platelets ≥25,000/mcL
    • total bilirubin ≤ 2 × institutional upper limit of normal (ULN) unless related to Gilbert's disease
    • AST(SGOT)/ALT(SGPT) ≤ 3 × institutional ULN
    • creatinine clearance < 1.5 x institutional ULN
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion Criteria:

  • Participants who have had chemotherapy or radiotherapy within 1 weeks (4 weeks for nitrosoureas or mitomycin C) prior to entering the study or those who have not recovered from adverse events due to agents administered more than 4 weeks earlier.
  • Participants who are receiving any other investigational agents for their lymphoma.
  • Participants receiving corticosteroids within the past 1 week.
  • Participants with known active CNS involvement by lymphoma should be excluded from this clinical trial because of their poor prognosis and because they often develop progressive neurologic dysfunction that would confound the evaluation of neurologic and other adverse events.
  • History of allergic reactions attributed to cyclophosphamide or alemtuzumab
  • Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, uncontrolled hematuria related to bladder injury or psychiatric illness/social situations that could limit compliance with study requirements.
  • Pregnant women are excluded from this study because cyclophosphamide and alemtuzumab at these doses have the potential for teratogenic or abortifacient effects. Because there is an unknown but potential risk for adverse events in nursing infants secondary to treatment of the mother with these agents, breastfeeding should be discontinued. Negative serum pregnancy test will be required for women of childbearing potential.
  • HIV-positive participants on combination antiretroviral therapy are ineligible because of the increased risk of lethal infections when treated with marrow-suppressive therapy.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03132584


Contacts
Contact: Ann LaCasce, MD 617-632-5959 ALACASCE@PARTNERS.ORG

Locations
United States, Massachusetts
Brigham and Women's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Ann LaCasce, MD    617-632-5959    ALACASCE@PARTNERS.ORG   
Principal Investigator: Ann LaCasce, MD         
Dana Farber Cancer Institute Recruiting
Boston, Massachusetts, United States, 02115
Contact: Ann LaCasce, MD    617-632-5959    ALACASCE@PARTNERS.ORG   
Principal Investigator: Ann LaCasce, MD         
Sponsors and Collaborators
Dana-Farber Cancer Institute
Genzyme, a Sanofi Company
Sanofi
Investigators
Principal Investigator: Ann LaCasce, MD Dana-Farber Cancer Institute

Responsible Party: Ann S. LaCasce, MD, Prinicipal Investigator, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT03132584     History of Changes
Other Study ID Numbers: 17-034
First Posted: April 28, 2017    Key Record Dates
Last Update Posted: September 18, 2017
Last Verified: September 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Ann S. LaCasce, MD, Dana-Farber Cancer Institute:
Non Hodgkin Lymphoma

Additional relevant MeSH terms:
Lymphoma
Lymphoma, Non-Hodgkin
Lymphoma, B-Cell
Lymphoproliferative Disorders
Neoplasms by Histologic Type
Neoplasms
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Cyclophosphamide
Alemtuzumab
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists