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Cutaneous T-Cell Non-Hodgkin LymphomaPhase 1NCT02548468

Reduced Intensity Conditioning Before Partially Matched Donor Stem Cell Transplant in Treating Patients With Advanced Cutaneous T Cell Lymphoma

A Phase 1 study testing Fludarabine, Total-Body Irradiation and T Cell-Depleted Donor Lymphocyte Infusion in people with Cutaneous T-Cell Non-Hodgkin Lymphoma and Recurrent Mycosis Fungoides and Sezary Syndrome, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Official record
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Trial summary

This phase I trial studies the side effects and the best dose of donor lymphocyte infusion when given together with reduced intensity conditioning regimen before partially matched donor stem cell transplant in treating patients with stage IIB-IV mycosis fungoides or Sezary syndrome. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Fludarabine, Total-Body Irradiation and T Cell-Depleted Donor Lymphocyte Infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
0 participants
Where
No sites listed yet
Study dates
20 Nov 2015to 16 Mar 2017
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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Stage IIB-IV mycosis fungoides and sezary syndrome who have failed at least one standard systemic therapy or are not candidates for standard therapy.
  • Patient should have a responsive skin disease including complete remission (CR) and partial remission (PR) (close to CR; 75%-99% clearance of skin disease from baseline without new tumors (T3) in patients with T1, T2 or T4 only skin disease) and should not have visceral organ or lymph node involvement prior to transplantation.
  • Patients must have a related donor who is a two or more allele mismatch at the HLA-A; B; C; DR and DQ loci. Patients who have sibling donors with a one antigen mismatch due to recombination will not be enrolled in this protocol.
  • Patients must have adequate organ function:
  • Left Ventricular Ejection Fraction (LVEF) of >50%
  • Carbon Monoxide Diffusing Capacity (DLCO) >50% of predicted corrected for hemoglobin
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  • Adequate liver function as defined by a serum bilirubin <2.0 (unless hemolysis or Gilbert disease), Aspartate aminotransferase (AST) or Alanine aminotransferase (ALT) < 2.5 X upper limit of normal
  • Creatinine clearance of > 60 ml/min
  • Performance status > 80% (Karnofsky)
  • Hematopoietic Cell Transplantation Specific Comorbidity Index (HCT-CI) <5 for age < 65, HCT-CI <4 for age >65
  • Patients must be willing to use contraception if they have childbearing potential
  • Able to give informed consent, or their legally authorized representative can give informed consent.

Who cannot join

  • Performance status of < 80% (Karnofsky)
  • HIV positive
  • Active involvement of the central nervous system with malignancy
  • Psychiatric disorder that would preclude patients from signing an informed consent
  • Pregnancy, or unwillingness to use contraception if they are have childbearing potential.
  • Patients with life expectancy of < 6 months for reasons other than their underlying hematologic/oncologic disorder or complications there from.
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  • Patients who have received alemtuzumab within 8 weeks of transplant admission, or who have recently received horse or rabbit anti-thymocyte globulin (ATG) and have ATG levels of > 2 μgm/ml.
  • Patients who cannot receive cyclophosphamide
  • Patients with evidence of another malignancy (exclusive of a skin cancer that requires only local treatment);
  • Patients with prior malignancies diagnosed> 5 years ago without evidence of disease are eligible.
  • Patients with prior malignancy treated < 5 years ago but have a life expectancy of > 5 years for that malignancy are eligible.
  • Uncontrolled active infection

About this study

Official title: A Two-Step Approach to Reduced Intensity Allogeneic Hematopoietic Stem Cell Transplantation for Advanced Cutaneous T Cell Lymphoma

This phase I trial studies the side effects and the best dose of donor lymphocyte infusion when given together with reduced intensity conditioning regimen before partially matched donor stem cell transplant in treating patients with stage IIB-IV mycosis fungoides or Sezary syndrome. Giving chemotherapy and low-dose total-body irradiation followed by high-dose cyclophosphamide before a donor peripheral blood stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. Sometimes the transplanted cells from a donor can make an immune response against the body's normal cells (called graft-versus-host disease). Removing the T-cells from the donor cells and giving them before transplant may stop this from happening. Additionally, giving tacrolimus and mycophenolate mofetil before and after transplant may also stop this from happening.

Read the detailed description

PRIMARY OBJECTVES:

  1. To evaluate regimen related toxicity, engraftment and graft versus host disease (GVHD) in the first 100 days with new reduced intensity haploidentical regimen protocol, including fludarabine (fludarabine phosphate), low dose total body irradiation, and cyclophosphamide.

II. To determine an effective donor lymphocyte infusion (DLI) dose that provides successful engraftment without causing GVHD.

SECONDARY OBJECTIVES:

  1. To assess myeloid and lymphoid engraftment rates of patients undergoing treatment on this regimen.

II. To determine the incidence and severity of GVHD in patients undergoing treatment on this regimen using a combination of tacrolimus and mycophenolate mofetil (MMF) as GVHD prophylaxis.

III. To examine progression free survival and overall survival in patients with cytotoxic T-cell lymphoma (CTCL) undergoing treatment on this regimen.

IV. To assess the pace of lymphoid recovery in this patient population.

OUTLINE: This is a phase I, dose-escalation study of DLI.

REDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate intravenously (IV) over 30 minutes on days -11 to -8 and undergo total body irradiation twice daily (BID) on day -7. Patients also receive donor cluster of differentiation (CD)3+ enriched T lymphocyte infusion on day -6 and high-dose cyclophosphamide IV over 2 hours on days -3 to -2.

TRANSPLANT: Patients undergo allogeneic peripheral blood stem cell transplant (PBSCT) on day 0.

GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV with taper (drug wean) by day 60 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD.

After completion of treatment, patients are followed up periodically.

Being tested
Fludarabine, Total-Body Irradiation, T Cell-Depleted Donor Lymphocyte Infusion, Cyclophosphamide, Allogeneic Hematopoietic Stem Cell Transplantation
Medical subject headings
Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome

What participants receive

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

  • FludarabineDrug

    Also called Fludarabine phosphate, Fludara

    Given IV

  • Total-Body IrradiationRadiation

    Undergo TBI

  • T Cell-Depleted Donor Lymphocyte InfusionBiological

    Undergo donor CD3+ enriched T lymphocyte infusion

  • CyclophosphamideDrug

    Also called Endoxan, Cytoxan, Neosar, Procytox

    Given IV

  • Allogeneic Hematopoietic Stem Cell TransplantationProcedure or surgery

    Undergo allogeneic HSC transplant

  • Peripheral Blood Stem Cell TransplantationProcedure or surgery

    Undergo allogeneic PBSCT

  • Mycophenolate mofetilDrug

    Also called MMF

    Given IV

  • TacrolimusDrug

    Also called FK-506, Fujimycin, Prograf, Advagraf

    Given IV

Study groups in NCT02548468
Study groupRoleWhat they receive
Reduced Intensity Conditioning, DLI, PBSCTExperimentalREDUCED INTENSITY CONDITIONING: Patients receive fludarabine phosphate IV over 30 minutes on days -11 to -8 and undergo total body irradiation BID on day -7. Patients also receive donor CD3+ enriched T lymphocyte infusion on day -6 and high-dose cyclophosphamide IV over 2 hours on days -3 to -2. TRANSPLANT: Patients undergo allogeneic PBSCT on day 0. GVHD PROPHYLAXIS: Beginning on day -1, patients receive tacrolimus IV with taper (drug wean) by day 60 and mycophenolate mofetil IV BID on days -1 to 28 in the absence of GVHD.
Receives: Drug: Fludarabine; Radiation: Total-Body Irradiation; Biological: T Cell-Depleted Donor Lymphocyte Infusion; Drug: Cyclophosphamide; Procedure: Allogeneic Hematopoietic Stem Cell Transplantation; Procedure: Peripheral Blood Stem Cell Transplantation; Drug: Mycophenolate mofetil; Drug: Tacrolimus

What is being measured

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

  1. Rate of regimen-related toxicities

    Estimate of dose-specific rates of toxicity will be presented with corresponding confidence intervals using the exact method. The method of Atkinson and Brown will be used for any rate related to definition of dose limiting toxicity, due to two-stage sampling.

    Measured: Up to 100 days post-transplant

  2. Rate for hematopoietic engraftment

    Estimate of dose-specific rate for engraftment will be presented with corresponding confidence intervals using the exact method. The method of Atkinson and Brown will be used for any rate related to definition of dose limiting toxicity, due to two-stage sampling.

    Measured: Up to 100 days post-transplant

  3. Rate for immune reconstitution

    Estimate of dose-specific rate for immune reconstitution will be presented with corresponding confidence intervals using the exact method. The method of Atkinson and Brown will be used for any rate related to definition of dose limiting toxicity, due to two-stage sampling.

    Measured: Up to 100 days post-transplant

  4. Incidence of GVHD

    Measured: Up to 100 days post-transplant

  5. Maximum tolerated dose of DLI, determined according to dose limiting toxicities

    Measured: day -4

Secondary outcomes (7)

  1. Myeloid engraftment rate

    Measured: Up to 6 months post-transplant

  2. Lymphoid engraftment rate

    Measured: Up to 6 months post-transplant

  3. Incidence of GVHD using tacrolimus and mycophenolate mofetil prophylaxis

    Measured: Up to 6 months post-transplant

  4. Progression free survival

    Progression free survival will be estimated by the Kaplan-Meier method.

    Measured: Up to 6 months post-transplant

  5. Overall survival (OS)

    OS will be estimated by the Kaplan-Meier method.

    Measured: Up to 6 months post-transplant

  6. Rate of lymphoid recovery

    Measured: Up to 6 months post-transplant

  7. Incidence of adverse events

    All estimates of dose-specific rates (e.g., toxicity) will be presented with corresponding confidence intervals using the exact method. The method of Atkinson and Brown will be used for any rate related to definition of dose limiting toxicity, due to two-stage sampling.

    Measured: Up to 6 months

Timeline

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

  1. First posted14 Sep 2015 (estimated)
  2. Study start20 Nov 2015
  3. Primary completion23 Jan 2017
  4. Study completion16 Mar 2017

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
Masking
None (open label)
Enrolment
0 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02548468
Sponsor's protocol ID
15D.237
Other IDs
JT 6812
Status last verified
May 2025
First submitted
8 Sep 2015
Last updated
2 May 2025
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Fludarabine, Total-Body Irradiation and T Cell-Depleted Donor Lymphocyte Infusion in people with Cutaneous T-Cell Non-Hodgkin Lymphoma and Recurrent Mycosis Fungoides and Sezary Syndrome, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University.

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 12 inclusion and 12 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: withdrawn, as of the sponsor's last update on 2 May 2025. Status can change between updates, so confirm with the study contact before making plans.

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 withdrawn before enrolling participants, so there are no results.

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?

Rate of regimen-related toxicities (time frame: Up to 100 days post-transplant). The study lists 5 primary outcomes in all. 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 NCT02548468.

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 2 May 2025.

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