Hematologic MalignancyPhase 2NCT01532635

A Two-Step Approach to Bone Marrow Transplant Using Cells From Two Partially-Matched Relatives

A Phase 2 study testing Total Body Irradiation (TBI), Donor Lymphocyte Infusion (DLI) and Cyclophosphamide (CY) in people with Hematologic Malignancy and Leukemia, run by Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson University at 1 site 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

Who is it for?: Ages 18 years and older
Conditions the study is for: Hematologic Malignancy, Leukemia, Acute Lymphoblastic Leukemia
What is being tested?: Total Body Irradiation (TBI), Donor Lymphocyte Infusion (DLI) and Cyclophosphamide (CY)
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 4 participants
Where: 1 siteUnited States
Study dates: Mar 2012to May 2013
Phase: Phase 2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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

Any patient with a hematologic malignancy with residual disease (morphological, cytogenetic, molecular, or radiographic) after treatment with 1 or more chemotherapy regimens in whom achievement of remission with additional chemoradiotherapy is felt to be unlikely or who is in 3rd or greater CR. Patients with marrow based diseases in which the marrow biopsy does not meet criteria for active disease (i.e. <5% blasts in acute leukemia) but who does not have full count recovery will be eligible for treatment on this high risk trial.
Patients must have two related donors that meet an acceptable scenario as described above.
Patients must adequate organ function:
LVEF of >= 50%
DLCO (adjusted for hemoglobin) >= 50% of predicted
Adequate liver function as defined by a serum bilirubin =< 1.8, AST or ALT < 2.5X upper limit of normal

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Creatinine clearance of >= 60 ml/min
Karnofsky Performance Status of > 80 % on the modified KPS tool (see Appendix A).
Patients must be willing to use contraception if they have childbearing potential.
Able to give informed consent

Who cannot join

Modified KPS of < 80%
>= 5 Comorbidity Points on the HCT-CI Index (See Appendix B)
Class I or II antibodies against donor HLA antigens
HIV positive
Active involvement of the central nervous system with malignancy
Psychiatric disorder that would preclude patients from signing an informed consent

Show all 12Show fewer

Pregnancy, or unwillingness to use contraception if they have child bearing potential
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 level of >= 2 ugm/ml
Patients with active inflammatory processes (such as flair of an autoimmune disease) including T max > 101, or active tissue inflammation are excluded.
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

Thomas Jefferson University
Philadelphia, Pennsylvania, 19107

Other trials in United States

About this study

Official title: A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematologic Malignancies Using Two Related Donors

This phase II clinical trial studies how well two donors stem cell transplant work in treating patients with high-risk hematologic malignancies. After receiving radiation to help further treat the disease, patients receive a dose of donors' T cells. T cells can fight infection and react against cancer cells. Two days after donors' T cells are given, patients receive cyclophosphamide (CY) to help destroy the most active T cells that may cause tissue damage (called graft versus host disease or GVHD). Some of the less reactive T cells are not destroyed by CY and they remain in the patient to help fight infection. A few days after the CY is given, patients receive donors' stem cells to help their blood counts recover. Using two donors' stem cell transplant instead of one donor may be more effective in treating patients with high-risk disease and may prevent the disease from coming back.

Read the detailed description

PRIMARY OBJECTIVES:

To assess 1 year relapse free survival in patients undergoing hematopoietic stem cell transplant (HSCT) using the Thomas Jefferson University (TJU) 2 step approach using 2 donors.

SECONDARY OBJECTIVES:

To assess the consistency and pace of engraftment. II. To assess the pace of T cell and B cell immune recovery in patients in each arm.

III. To assess regimen related toxicity, graft-versus-host disease (GVHD) incidence and severity, and overall survival.

IV. To assess the tolerance of the period of fever, diarrhea, and rash after the introduction of second donor and qualitatively compare it to prior patient groups or concurrent patient groups.

To assess chimerism to ascertain whether one donor is emerging as dominant at regular intervals beginning at the time of engraftment.

VI. If dominance is observed, to compare the donors with regard to degree of human leukocyte antigen (HLA) mismatch, killer Ig-like receptor (KIR) types, cluster of differentiation (CD)34+ cell doses, infusion order, donor age, and donor alloreactivity points in an effort to identify potential biologic factors that predict for dominance. To determine if trends toward dominance occur in T cell, natural killer (NK) cell, or other cellular subsets prior to emerging in the graft as a whole.

VII. To assess if establishment of a dominant donor versus persistent chimerism of both donors is associated with a lower relapse rate.

VIII. To collect leukemia samples prior to transplant and after relapse whenever possible. To assess the overall degree of HLA-class I and class II expression on these paired samples. To test for loss of one or both HLA haplotypes in the relapsed tumor specimens. When observed, to correlate loss of one HLA haplotype with: a) receipt of a transplant capable of targeting only that haplotype; b) establishment of dominance in a 2 haplotype transplant such that the lost haplotype would be the primary target of the dominant donor; c) being the target of the donor predicted to be more alloreactive in a 2 haplotype transplant.

OUTLINE:

CONDITIONING: Patients undergo total-body irradiation (TBI) twice daily (BID) on days -9 to -6, undergo donor lymphocyte infusion (DLI) on day -6, and receive cyclophosphamide intravenously (IV) over 2 hours on days -3 and -2.

TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.

GVHD PROPHYLAXIS: Patients receive tacrolimus IV or orally (PO) beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28.

After completion of study treatment, patients are followed up for 1 year, and then periodically thereafter.

Conditions: Hematologic Malignancy, Leukemia, Acute Lymphoblastic Leukemia, ALL, Acute Myelogenous Leukemia, AML
Being tested: Total Body Irradiation (TBI), Donor Lymphocyte Infusion (DLI), Cyclophosphamide (CY), Tacrolimus, Mycophenolate Mofetil (MMF)
Keywords: hematologic malignancy, leukemia, Acute lymphoblastic leukemia, ALL, Acute myelogenous leukemia, AML, Chronic lymphocytic leukemia, CLL, lymphoma, hodgkin's lymphoma, non-hodgkin's lymphoma, myeloma, allogeneic stem cell transplant, TJU 2-step, Hematopoietic stem cell transplant, HSCT, bone marrow transplant, Cyclophosphamide, MMF, Mycophenolate Mofetil
Medical subject headings: Hematologic Neoplasms, Leukemia, Precursor Cell Lymphoblastic Leukemia-Lymphoma, Leukemia, Myeloid, Acute, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, Hodgkin Disease, Lymphoma, Non-Hodgkin

What participants receive

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

Total Body Irradiation (TBI)Radiation
Also called TBI, radiotherapy
TBI twice daily for 4 days and occurs 6 to 9 days prior to the transplant. Total radiation dose is 12 Gy.
Donor Lymphocyte Infusion (DLI)Biological
Also called DLI, T cell infusion
DLI given 6 days prior to transplant (HSCT).
Cyclophosphamide (CY)Drug
Also called CY, Endoxan, Cytoxan, Neosar
Cyclophosphamide given once daily at 60 mg/kg on days 2 and 3 prior to transplant (HSCT).
TacrolimusDrug
Also called FK-506, fujimycin, Prograf, Advagraf
Tacrolimus is started the day before the transplant and stops a few months after transplant.
Mycophenolate Mofetil (MMF)Drug
Also called MMF, CellCept, Myfortic
MMF is started the day before transplant and stops a few weeks after transplant.
Hematopoietic Stem Cell Transplant (HSCT)Biological
Also called HSCT, stem cell transplant, CliniMACS
CD34+ selected Hematopoietic Stem Cell Transplant (HSCT) is performed using donor cells from two related donors.
The CliniMACS® Plus Instrument will be used for the selection of human CD34+ hematopoietic stem cells.

Study groups in NCT01532635
Study group	Role	What they receive
Allogeneic HSCT Using Two Related Donors	Experimental	CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28. Receives: Radiation: Total Body Irradiation (TBI); Biological: Donor Lymphocyte Infusion (DLI); Drug: Cyclophosphamide (CY); Drug: Tacrolimus; Drug: Mycophenolate Mofetil (MMF); Biological: Hematopoietic Stem Cell Transplant (HSCT)

What is being measured

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

One Year Relapse-Free Survival
To assess one year relapse-free survival (RFS) in patients undergoing HSCT (hematopoietic stem cell transplantation) using the TJU 2 step-approach with two donors.
Survival will be estimated by the Kaplan-Meier method. All estimates of rates will be presented with corresponding confidence intervals. For 1 year RFS rates, the method of Atkinson and Brown will be used to allow for the two-stage design; otherwise the method of Conover.
Measured: 1 year

Secondary outcomes (8)

Chimerism Assessment
To assess chimerism to ascertain whether one donor is emerging as dominant at regular intervals beginning at the time of engraftment.
Measured: 1 year
Assessment of Dominance
If dominance is observed, to compare the 2 donors with regard to degree of HLA mismatch, KIR types, CD 34+ cell doses, infusion order, donor age, and donor alloreactivity points in an effort to identify potential biologic factors that predict for dominance. To determine if trends toward dominance occur in T cell, NK cell, or other cellular subsets prior to emerging in the graft as a whole.
Measured: 1 year
Relapse Rates
To assess if establishment of a dominant donor versus persistent chimerism of both donors is associated with a lower relapse rate.
Measured: 1 year
Engraftment
To assess the consistency and pace of engraftment of both donors.
Measured: 1 year
Immune Reconstitution
Assess T and B cell Reconstitution
Measured: 1 year
Non-relapse Morbidity and Mortality
Assessment of regimen related toxicity, GVHD incidence and severity, and overall survival.
Measured: 1 year
Tolerance of DLI
Assessment of the tolerance of the period of fever, diarrhea, and rash after the introduction of second donor and qualitatively compare it to prior patient groups or concurrent patient groups
Measured: 2-6 days prior to transplant
Assessment for Tumor Escape Mechanisms
To test for loss of one or both HLA haplotypes in patients who relapse post-transplant and examine the relapse in the context of the characteristics of the 2 donors
Measured: 1 year post transplant

Timeline

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

Mar 2012May 2013

First posted14 Feb 2012 (estimated)
Study startMar 2012
Primary completionFeb 2013
Study completionMay 2013

Why it stopped: Slow accrual

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Hematologic MalignancyStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 4 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01532635
Sponsor's protocol ID: 11D.570
Other IDs: 2011-101, JT 1832
Status last verified: May 2025
First submitted: 6 Feb 2012
Last updated: 4 May 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Two Step Approach to Allogeneic Hematopoietic Stem Cell Transplantation for High-Risk Hematologic Malignancies Using Two Related Donors
ClinicalTrials.gov ID: NCT01532635
Acronym / sponsor ID: 11D.570
Conditions: Hematologic Malignancy, Leukemia, Acute Lymphoblastic Leukemia, ALL, Acute Myelogenous Leukemia, AML
Keywords: hematologic malignancy, leukemia, Acute lymphoblastic leukemia, ALL, Acute myelogenous leukemia, AML, Chronic lymphocytic leukemia, CLL
Phase: Phase 2
Study type: Interventional
Recruitment status: TerminatedReason stopped: Slow accrual
Enrolment: 4 participants (actual)
Lead sponsor: Sidney Kimmel Comprehensive Cancer Center at Thomas Jefferson UniversityUniversity, hospital or other
Study start: Mar 2012
Primary completion: Feb 2013 (actual)
Study completion: May 2013 (actual)
First posted: 14 Feb 2012 (estimated)
Results: Posted 10 Nov 2014

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

PRIMARY OBJECTIVES:

To assess 1 year relapse free survival in patients undergoing hematopoietic stem cell transplant (HSCT) using the Thomas Jefferson University (TJU) 2 step approach using 2 donors.

SECONDARY OBJECTIVES:

To assess the consistency and pace of engraftment. II. To assess the pace of T cell and B cell immune recovery in patients in each arm.

III. To assess regimen related toxicity, graft-versus-host disease (GVHD) incidence and severity, and overall survival.

IV. To assess the tolerance of the period of fever, diarrhea, and rash after the introduction of second donor and qualitatively compare it to prior patient groups or concurrent patient groups.

To assess chimerism to ascertain whether one donor is emerging as dominant at regular intervals beginning at the time of engraftment.

VII. To assess if establishment of a dominant donor versus persistent chimerism of both donors is associated with a lower relapse rate.

OUTLINE:

TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0.

GVHD PROPHYLAXIS: Patients receive tacrolimus IV or orally (PO) beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28.

After completion of study treatment, patients are followed up for 1 year, and then periodically thereafter.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Allogeneic HSCT Using Two Related Donors	Experimental	Radiation: Total Body Irradiation (TBI), Biological: Donor Lymphocyte Infusion (DLI), Drug: Cyclophosphamide (CY), Drug: Tacrolimus, Drug: Mycophenolate Mofetil (MMF), Biological: Hematopoietic Stem Cell Transplant (HSCT)CONDITIONING: Patients undergo TBI BID on days -9 to -6, undergo DLI on day -6, and receive cyclophosphamide IV over 2 hours on days -3 and -2. TRANSPLANTATION: Patients undergo CD34+ selected allogeneic HSCT on day 0. GVHD PROPHYLAXIS: Patients receive tacrolimus IV or PO beginning on day -1 with taper beginning on day 42 and mycophenolate mofetil IV or PO BID on days -1 to 28.

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (10 listed)

Any patient with a hematologic malignancy with residual disease (morphological, cytogenetic, molecular, or radiographic) after treatment with 1 or more chemotherapy regimens in whom achievement of remission with additional chemoradiotherapy is felt to be unlikely or who is in 3rd or greater CR. Patients with marrow based diseases in which the marrow biopsy does not meet criteria for active disease (i.e. <5% blasts in acute leukemia) but who does not have full count recovery will be eligible for treatment on this high risk trial.
Patients must have two related donors that meet an acceptable scenario as described above.
Patients must adequate organ function:
Karnofsky Performance Status of > 80 % on the modified KPS tool (see Appendix A).
Patients must be willing to use contraception if they have childbearing potential.

Key exclusion criteria (12 listed)

Modified KPS of < 80%
>= 5 Comorbidity Points on the HCT-CI Index (See Appendix B)
Class I or II antibodies against donor HLA antigens
HIV positive
Active involvement of the central nervous system with malignancy

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Total Body Irradiation (TBI)Also: TBI, radiotherapyTBI twice daily for 4 days and occurs 6 to 9 days prior to the transplant. Total radiation dose is 12 Gy.	Radiation	Allogeneic HSCT Using Two Related Donors
Donor Lymphocyte Infusion (DLI)Also: DLI, T cell infusionDLI given 6 days prior to transplant (HSCT).	Biological	Allogeneic HSCT Using Two Related Donors
Cyclophosphamide (CY)Also: CY, Endoxan, Cytoxan, NeosarCyclophosphamide given once daily at 60 mg/kg on days 2 and 3 prior to transplant (HSCT).	Drug	Allogeneic HSCT Using Two Related Donors
TacrolimusAlso: FK-506, fujimycin, Prograf, AdvagrafTacrolimus is started the day before the transplant and stops a few months after transplant.	Drug	Allogeneic HSCT Using Two Related Donors
Mycophenolate Mofetil (MMF)Also: MMF, CellCept, MyforticMMF is started the day before transplant and stops a few weeks after transplant.	Drug	Allogeneic HSCT Using Two Related Donors
Hematopoietic Stem Cell Transplant (HSCT)Also: HSCT, stem cell transplant, CliniMACSCD34+ selected Hematopoietic Stem Cell Transplant (HSCT) is performed using donor cells from two related donors. The CliniMACS® Plus Instrument will be used for the selection of human CD34+ hematopoietic stem cells.	Biological	Allogeneic HSCT Using Two Related Donors

Primary outcome

One Year Relapse-Free Survival
Time frame: 1 year
To assess one year relapse-free survival (RFS) in patients undergoing HSCT (hematopoietic stem cell transplantation) using the TJU 2 step-approach with two donors. Survival will be estimated by the Kaplan-Meier method. All estimates of rates will be presented with corresponding confidence intervals. For 1 year RFS rates, the method of Atkinson and Brown will be used to allow for the two-stage design; otherwise the method of Conover.

8 secondary outcomes

Chimerism Assessment
Time frame: 1 year
Assessment of Dominance
Time frame: 1 year
Relapse Rates
Time frame: 1 year
Engraftment
Time frame: 1 year
Immune Reconstitution
Time frame: 1 year
Non-relapse Morbidity and Mortality
Time frame: 1 year
Tolerance of DLI
Time frame: 2-6 days prior to transplant
Assessment for Tumor Escape Mechanisms
Time frame: 1 year post transplant

Results and safety

Results posted to the registry on 10 Nov 2014, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Allogeneic HSCT Using Two Related Donors	4	4

Primary outcome: One Year Relapse-Free Survival

Time frame: 1 year

8 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Allogeneic HSCT Using Two Related Donors	3 of 4 (75%)	4 of 4 (100%)	Not reported

Limitations and caveats (from the sponsor): Study was terminated due to poor accrual. No reportable data has been collected.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 May 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Kimmel Cancer Center at Thomas Jefferson University, an NCI-Designated Cancer CenterLink provided by the sponsor.
Thomas Jefferson University HospitalsLink provided by the sponsor.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Neal Flomenberg, MD principal investigator

Thomas Jefferson University

Dolores Grosso, DNP, CRNP principal investigator

Thomas Jefferson University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 10 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: stopped early, as of the sponsor's last update on 4 May 2025. 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?

Yes. Results are posted in the registry (first posted 10 Nov 2014). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

One Year Relapse-Free Survival (time frame: 1 year). 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 NCT01532635.

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 4 May 2025.