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Non Hodgkin LymphomaPhase 1NCT03132584

Cyclophosphamide and Alemtuzumab In Lymphoma

A Phase 1 study testing Cyclophosphamide and Alemtuzumab in people with Non Hodgkin Lymphoma and High-grade B-cell Lymphoma, run by Dana-Farber Cancer Institute at 2 sites in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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 Read more about this study

Who is it for?
Ages 18 to 75 years
What is being tested?
Cyclophosphamide and Alemtuzumab
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
3 participants
Where
2 sitesUnited States
Study dates
30 Jul 2017to 30 Jan 2018
Phase
Phase 1
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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.

Trial locations and contacts

2 sites in 1 country.

United States2 sites

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02115

  • Dana Farber Cancer Institute

    Boston, Massachusetts, 02115

Other trials in United States

About this study

Official title: Ph1 Cyclophosphamide & Alemtuzumab in CD52+ R/R Double-Hit, Diffuse Lg B-cell or High Gr B-cell Lymphomas, NOS With MYC & BCL2 Over-expression, MYC-Positive Transformed Follicular Lymphoma, & CD52+ Mature T-cell Lymphoproliferative Disorder

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
Read the 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.

Being tested
Cyclophosphamide, Alemtuzumab
Keywords
Non Hodgkin Lymphoma
Medical subject headings
Lymphoma, Non-Hodgkin, Lymphoma, Large B-Cell, Diffuse

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CyclophosphamideDrug

    Also called Endoxan, Cytoxan, Lyophilized Cytoxan, Neosar

    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

  • AlemtuzumabDrug

    Also called Campath

    • 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
Study groups in NCT03132584
Study groupRoleWhat they receive
Cyclophosphamide and AlemtuzumabExperimentalAfter 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
Receives: Drug: Cyclophosphamide; Drug: Alemtuzumab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. MTD of Cyclophosphamide and Alemtuzumab

    maximum tolerated dose of the combination of cyclophosphamide and alemtuzumab

    Measured: 28 days

Secondary outcomes (5)

  1. Overall Response Rate

    Non-Hodgkin Lymphoma Response Criteria, which will be reported descriptively

    Measured: 12 Months

  2. Complete Response Rate

    Non-Hodgkin Lymphoma Response Criteria, which will be reported descriptively

    Measured: 12 Months

  3. Progression Free Survival

    Progression-free will be estimated using the method of Kaplan and Meier.

    Measured: up to 5 years

  4. Overall Survival

    Overall survival will be estimated using the method of Kaplan and Meier.

    Measured: up to 5 years

  5. Response Rate

    Assess response by PET/CT and in the bone marrow after one cycle of therapy

    Measured: 28 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted28 Apr 2017
  2. Study start30 Jul 2017
  3. Primary completion30 Jan 2018
  4. Study completion30 Jan 2018

Why it stopped: slow accrual

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This is a phase I study in the standard 3+3 dose escalation design
Masking
None (open label)
Enrolment
3 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03132584
Sponsor's protocol ID
17-034
Status last verified
Jan 2019
First submitted
24 Apr 2017
Last updated
14 Jan 2019
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Cyclophosphamide and Alemtuzumab in people with Non Hodgkin Lymphoma and High-grade B-cell Lymphoma, run by Dana-Farber Cancer Institute at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 17 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 14 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: slow accrual). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

MTD of Cyclophosphamide and Alemtuzumab (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03132584.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jan 2019.

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