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AzTrials

Hematopoietic and Lymphoid Cell NeoplasmPhase 2NCT03032783

A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for Patients With Hematologic Malignancies-Increasing GVT Effects Without Increasing Toxicity

A Phase 2 study testing Total-Body Irradiation, Donor Lymphocyte Infusion and Cyclophosphamide in people with Hematopoietic and Lymphoid Cell Neoplasm, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This phase II trial studies the how well donor stem cell transplant works in treating patients with high risk hematologic malignancies. Giving total-body irradiation and chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells)… Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hematopoietic and Lymphoid Cell Neoplasm
What is being tested?
Total-Body Irradiation, Donor Lymphocyte Infusion and Cyclophosphamide
Could I receive a placebo?
No, everyone receives an active treatment
How many people
51 participants
Where
1 siteUnited States
Study dates
31 Jan 2017to 2 Dec 2025
Phase
Phase 2
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

  • This treatment is for patients with high risk hematologic malignancies. High risk is defined as:
  • Any patient with a hematologic malignancy in which allogeneic HSCT is pursued with the expectation of cure. Patients may have post-treatment residual disease, but the disease should be stable or minimally progressive and must be responsive to chemotherapy.
  • Any patient with an untreated hematologic malignancy in which allogeneic HSCT is thought to be the sole or the best option for cure and in Patients without morphologic evidence of disease but with high risk features which would predict for relapsed despite remission at HSCT such as adverse cytogenetics, 3rd or greater CR, or failure to recover peripheral blood counts to normal ranges. While these patients do not have detectable disease by current methods, like all patients they have non-detectable disease which in their case is highly aggressive.
  • Patients with uncommon diagnoses in which allogeneic HSCT is thought to be beneficial but are no comparable to the majority of patients on this protocol will not be counted in the statistical aims of the study and will be reported descriptively. The PI and at least one Co-I must document this exception in the study binder and the rationale for descriptive report. An example of a patient who may meet this criteria is someone with a malignancy that is an overlap of two different diagnoses or one whose malignancy is difficult to categorize. While this circumstance is expected to be rare, it will prevent patients with rare diagnoses to be treated off study and it will help maintain homogeneity of the study population.
  • Patients must have one related donor who is HLA mismatched in the GVHD direction at two or more HLA loci (except as described below)
  • Patients must have adequate organ function:
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  • Left Ventricular Ejection Fraction (LVEF) of ≥50%
  • DLCO (adjusted for hemoglobin) ≥50% of predicted and FEV-1 ≥50%
  • Adequate liver function as defined by a serum bilirubin ≤1.8, Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) ≤ 2.5 x Upper Limit of Normal (ULN)
  • Creatinine clearance of ≥ 60ml/min
  • Karnofsky Performance Status (KPS) of ≥80% on the modified KPS tool (see Appendix)
  • Patients must be willing to use contraception if they have childbearing potential
  • Able to give informed consent
  • Age ≥ 18 years of age

Who cannot join

  • Modified KPS of <80%
  • > 5 Comorbidity Points on the Hematopoietic Cell Transplant Co-Morbidity Index (HCT CI) (See Appendix) (Patients with greater than 5 points will be allowed for trial with approval of the PI and at least 1 Co-I not on the primary care team of the patient.) this is an adjustment to account for healthy patients who meet the spirit of this protocol but have histories that result in higher than HCT-CI 5 points. An example is a patient with a solid tumor malignancy in their remote history (adds 3 points to HCT-CI total) where the treatment for the malignancy occurred years to decades before and there has been complete recovery of toxicities.
  • Human Immunodeficiency Virus (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 have childbearing potential
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  • Patients with life expectancy of ≤ 6 months for reasons other than their underlying hematologic/oncologic disorder
  • Alemtuzumab treatment within 8 weeks of HSCT admission
  • ATG within 8 weeks of HSCT administration
  • Inability to tolerate cyclophosphamide or undergo total body irradiation at the doses specified in the treatment plan.

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University

    Philadephia, Pennsylvania, 19107

Other trials in United States

About this study

This phase II trial studies the how well donor stem cell transplant works in treating patients with high risk hematologic malignancies. Giving total-body irradiation and chemotherapy before a donor stem cell transplant helps stop the growth of cells in the bone marrow, including normal blood-forming cells (stem cells) and cancer cells. It may also stop the patient's immune system from rejecting the donor's stem cells. When the healthy stem cells from a donor are infused into the patient they may help the patient's bone marrow make stem cells, red blood cells, white blood cells, and platelets. The donated stem cells may also replace the patient's immune cells and help destroy any remaining cancer cells.

Read the detailed description

Primary Objective:

  1. To assess 2 year probability of OS in high risk patients undergoing a myeloablative 2 step HSCT utilizing strategies to decrease relapse.

Secondary Objective:

  1. To assess relapse incidence at 2 years post-HSCT of patients undergoing treatment on this protocol.
  2. To assess regimen related toxicity and GVHD incidence at 2 years post-HSCT and severity in patients undergoing treatment on this protocol.
  3. To assess the consistency and pace of engraftment.
  4. To assess the pace of T cell and B cell immune recovery.
Medical subject headings
Hematologic Neoplasms

What participants receive

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

  • Total-Body IrradiationRadiation

    Also called Total Body Irradiation

    Undergo Total Body Irradiation

  • Donor Lymphocyte InfusionProcedure or surgery

    Also called DLI, Donor Leukocyte Infusion

    Undergo Donor Lymphocyte Infusion

  • CyclophosphamideDrug

    Also called (-)-Cyclophosphamide, 1-bis(2-chloroethyl)-amino-1-oxo-2-aza-5-oxaphosphoridin monohydrate, 2-[bis(2-chloroethyl)amino]tetrahydro-2H-1,3,2-oxazaphosphorine 2-oxide monohydrate, 6055-19-2

    Given IV

  • TacrolimusDrug

    Also called Fujimycin, 717865, 109581-93-3, Hecoria

    Given IV

  • Mycophenolate MofetilDrug

    Also called 115007-34-6, 128794-94-5, 724229, Cellcept

    Given IV

  • Allogeneic Hematopoietic Stem Cell TransplantationProcedure or surgery

    Also called HSCT, HSC

    Undergo Hematopoietic Stem Cell Transplantation

Study groups in NCT03032783
Study groupRoleWhat they receive
Treatment (TBI, DLI, chemotherapy, HSCT)ExperimentalPatients undergo Total-Body Irradiation (TBI) twice daily on days -10 to -8 and and donor lymphocyte infusion (DLI) on day -6. Patients receive cyclophosphamide IV on days -3 and -2, tacrolimus IV beginning on day -1 and then orally at least 2 or 3 days prior to discharge with taper starting on day 42, and mycophenolate mofetil IV twice daily on days -1 to 28. Patients undergo Allogeneic Hematopoietic Stem Cell Transplantation on day 0.
Receives: Radiation: Total-Body Irradiation; Procedure: Donor Lymphocyte Infusion; Drug: Cyclophosphamide; Drug: Tacrolimus; Drug: Mycophenolate Mofetil; Procedure: Allogeneic Hematopoietic Stem Cell Transplantation

What is being measured

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

  1. Overall Survival (OS)

    Will be tested using an exact one-sided binomial test with alpha 0.05. The trial will be considered successful if the null hypothesis of 45% 2-year OS is rejected. In addition, the exact binomial 95% confidence interval for 2-year OS will be computed.

    Measured: At two years

Secondary outcomes (2)

  1. Incidence of graft failure

    Should be less than 10%

    Measured: Up to 2 years

  2. Incidence of non-relapse mortality

    Should be less than 20% at 100 days

    Measured: Up to 2 years

Timeline

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

  1. First posted26 Jan 2017 (estimated)
  2. Study start31 Jan 2017
  3. Primary completion2 Dec 2025
  4. Study completion2 Dec 2025

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
51 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03032783
Sponsor's protocol ID
16D.606
Other IDs
JT 9551
Status last verified
Jan 2026
First submitted
24 Jan 2017
Last updated
29 Jan 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Total-Body Irradiation, Donor Lymphocyte Infusion and Cyclophosphamide in people with Hematopoietic and Lymphoid Cell Neoplasm, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site 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 14 inclusion and 10 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: finished, as of the sponsor's last update on 29 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Overall Survival (OS) (time frame: At two years). 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 NCT03032783.

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 29 Jan 2026.

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