Hematological MalignancyPhase 2NCT03159702

Propylene Glycol-Free Melphalan HCl (EVOMELA®) in Combination With Fludarabine and Total Body Irradiation Based Reduced Intensity Conditioning for Haploidentical Transplantation

A Phase 2 study testing Evomela, Fludarabine and Total Body Irradiation in people with Hematological Malignancy and Multiple Myeloma, run by Medical College of Wisconsin 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 is an open-label, single-arm, phase II study to determine the safety of propylene glycol-free melphalan HCl (EVOMELA®), in combination with fludarabine and total-body irradiation-based reduced-intensity conditioning for haploidentical transplantation. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Hematological Malignancy, Multiple Myeloma
What is being tested?: Evomela, Fludarabine and Total Body Irradiation
Type of treatment: Injection or infusion, Surgery or procedure
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 43 participants
Where: 1 siteUnited States
Study dates: 8 Dec 2017to 8 Dec 2025
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

Patients with a diagnosis of hematological malignancy undergoing a related donor haploidentical HCT.*
Patients aged ≥18 are eligible.
Bilirubin ≤ 2 x the upper limit of normal (ULN). For patients with Gilbert's syndrome or suspected mild veno-occlusive disease, bilirubin ≤ 3 x ULN is permitted.
Adequate renal function as defined by a serum creatinine clearance of > 30 mL/min calculated by Cockcroft-Gault equation.
Left ventricular ejection fraction ≥40%. No uncontrolled arrhythmias or New York Heart Association class III-IV heart failure.
Forced expiratory volume (FEV1) or diffusion capacity for carbon monoxide (DLCO) corrected for hemoglobin ≥ 50% of predicted.

Show all 12Show fewer

Karnofsky performance status > 60.
Graft source of peripheral blood (the infused cluster of differentiation 34 (CD34)+ cell dose will be capped at 5 x 10^6 CD34+ cells/kg recipients actual body weight) or bone marrow (the ideal infused total nucleated cell dose (TNC) will be targeted at 4 x 10^8/kg recipient actual body weight).
A negative pregnancy test will be required for all women of child bearing potential. Females of child bearing potential should agree to practice 2 effective methods of contraception, at the same time, from the time of signing the informed consent form through 90 days after the last dose of study drug and must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, or agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence [e.g., calendar, ovulation, symptothermal, postovulation methods] and withdrawal are not acceptable methods of contraception.). Breast-feeding is not permitted.
Male patients, even if surgically sterilized (i.e., status post-vasectomy), must agree to one of the following: practice effective barrier contraception during the entire study treatment period and through 90 days after the last dose of study drug, or must also adhere to the guidelines of any treatment-specific pregnancy prevention program, if applicable, or agree to practice true abstinence when this is in line with the preferred and usual lifestyle of the subject. (Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods] and withdrawal are not acceptable methods of contraception.)
No evidence of uncontrolled bacterial, viral or fungal infections at the time of enrollment.
Transplant recipient able to give informed consent. * Patients must be human leukocyte antigen (HLA) typed at high resolution using DNA based typing at the following HLA loci: HLA-A, -B, -C and DRB1 and have available: A related haploidentical bone marrow donor with two, three or four HLA-mismatches. A unidirectional mismatch in either the graft-versus-host or host-versus-graft direction is considered a mismatch. The donor and recipient must be HLA identical for at least one antigen (using high-resolution DNA-based typing) at the following genetic loci: HLA-A, HLA-B, HLA-C, and HLA-DRB1. Fulfillment of this criterion shall be considered sufficient evidence that the donor and recipient share one HLA haplotype, and typing of additional family members is not required.

Who cannot join

Patient must not have a healthy, eligible and readily available HLA-identical sibling donor or a volunteer adult unrelated donor (matched at allele-level at HLA-A, -B, -C and -DRB1).
No serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.\
Presence of active disease in acute myeloid leukemia (AML)/myelodysplastic syndrome (MDS): patients with active disease defined as >5% blasts in bone marrow and/or circulating leukemic blasts in peripheral blood, patients with known active central nervous disease involvement with leukemia/lymphoma or lymphoma patients with progressive disease on clinical and/or radiographic assessment are not eligible for this study.

Trial locations and contacts

1 site in 1 country.

United States1 site

Froedtert Hospital & the Medical College of Wisconsin
Milwaukee, Wisconsin, 53226

Other trials in United States

About this study

Read the detailed description

OVERVIEW:

Elderly and infirm patients with hematological malignancies often cannot undergo allogeneic hematopoietic cell transplantation (HCT) because of high-toxicity rates and nonrelapse mortality (NRM) associated with higher-intensity conditioning allografts.

Reduced-intensity conditioning (RIC) transplantation has emerged as an attractive alternative for these populations.

FLUDARABINE/MELPHALAN. In RIC, fludarabine is often used as the lymphocyte-depleting component to facilitate donor-cell engraftment. This drug can be given once daily because of its plasma half-life. M.D. Anderson pioneered the use of fludarabine melphalan (FLU/MEL) conditioning, which has since gained wide usage. (1) Melphalan is convenient, has broad antitumor activity in hematologic malignancies and has immunosuppressive effects. The Flu/Mel conditioning regimen can provide long-term disease control, especially in the subset of patients with chemo sensitive disease. (1) TOTAL-BODY IRRADIATION. In a recent study, total-body irradiation (200 cGy) was used with flu/mel for advanced lymphoma treated with HCT. With a median follow-up time close to two years, the survival of these mostly advanced, relapsed/refractory patients was very encouraging with overall survival of 54% and progression-free survival of 54% for the entire group. (2) Treatment-related mortality was low at day 100 (9.1%) and two years (19%) after transplantation, with stable engraftment achieved in the great majority of patients.

PROPYLENE GLYCOL-FREE MELPHALAN HCL (EVOMELA®). In theory, intensifying the dose of melphalan in flu/mel conditioning could provide better disease control post HCT, allowing more time for curative graft-versus-leukemia effects to emerge. The use of the commercial formulation of melphalan (Alkeran®) proved somewhat problematic, however, because it must be reconstituted with propylene glycol, a substance that has been associated with toxic side effects. The substitution of Captisol® in propylene glycol-free melphalan HCl (EVOMELA®) for Injection (Spectrum Pharmaceuticals, Inc.) for the excipients found in Alkeran®, directly overcomes the formulation limitations noted with Alkeran®.

STUDY RATIONALE. The preliminary data suggest that the substitution of Captisol® in EVOMELA® for the excipients found in Alkeran® directly overcomes the formulation limitations and provides a potentially safer melphalan formulation for administration at higher doses used in HCT conditioning regimens.

Based on these observations, we now propose a phase II study of a RIC regimen consisting of EVOMELA® in combination with fludarabine and total-body irradiation for patients undergoing haplo-HCT. The study will investigate the safety and tolerability of this conditioning approach. While the FDA indication for EVOMELA® is for myeloablative conditioning prior to autologous HCT in patients with multiple myeloma, we anticipate our study will provide critical preliminary data to explore this formulation in allogeneic HCT conditioning.

Conditions: Hematological Malignancy, Multiple Myeloma
Being tested: Evomela, Fludarabine, Total Body Irradiation, Haploidentical Hematopoietic Cell Transplantation
Keywords: hematological malignancy, EVOMELA, Melphalan HCl, Total Body Irradiation, Reduced Intensity Conditioning, Haploidentical Transplantation, Fludarabine, Hematologic Diseases
Medical subject headings: Hematologic Neoplasms, Multiple Myeloma, Hematologic Diseases

What participants receive

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

EvomelaDrug
Also called Melphalan
140 mg/m^2/day IV on Day -6 for patients who are < 60 years of age. 70 mg/m^2/day IV on Day -6 For patients who are ≥60 years or have a HCT-CI score of >3
FludarabineDrug
Also called Fludara
40 mg/ m^2/day intravenous on Days: -5 -4, -3, -2
Total Body IrradiationRadiation
200 cGy on Day: -1
Haploidentical Hematopoietic Cell TransplantationOther
This is a procedure that uses healthy blood-forming cells from a half-matched donor, typically a family member, to replace a patient's unhealthy ones.

Study groups in NCT03159702
Study group	Role	What they receive
MEL/FLU and Total-Body Irradiation (TBI)	Experimental	For patients who are < 60 years. * Melphalan: 140 mg/m2/day IV on Day: -6 * Fludarabine: 40 mg/ m2/day IV Days: -5 -4, -3, -2 (Adults: creatinine clearance (CrCl) may be estimated by the Cockcroft Formula: CrCl = [(140-age) x weight (kg) x 0.85 (for women only)]/ [72 x creat (mg/dl)].) * TBI: 200 cGy Day: -1. For patients who are ≥60 years and/or Hematopoietic Cell Transplant-Co-morbidity Index (HCT-CI) score of >3 (at the discretion of treating physician will have an option to receive): * Melphalan: 70 mg/m2/day IV on Day -6. * Fludarabine: 40 mg/m2/day IV Days -5, -4, -3, -2. * TBI: 200 cGy; Days -1. Receives: Drug: Evomela; Drug: Fludarabine; Radiation: Total Body Irradiation; Other: Haploidentical Hematopoietic Cell Transplantation

What is being measured

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

Progression-free Survival (PFS) of Participants With Hematological Malignancies Undergoing Treatment.
Progression-free survival (PFS) is defined as the interval from the date of transplantation to the earlier of the following events: (1) the first documented objective disease progression; (2) death from any cause. Subjects without documented PD/death will be censored at the earliest of the of the following times: (1) the starting time of a new treatment other than the study treatment; (2) the last efficacy assessment date.
Measured: 1 year
Serious Adverse Events (SAE).
An SAE is defined as any untoward medical occurrence at any dose, including death, life threatening, hospitalization, disability/incapacity, medically important event. The measure of this outcome is the number of participants with SAEs.
Measured: 2 Years

Secondary outcomes (8)

Nonrelapse Mortality Rate.
This is the number of participants expiring without recurrent or progressive disease after transplantation.
Measured: 1 Year
Overall Survival
The number of participants still alive at one year and 2 years.
Measured: 1 Year and 2 Year
Number of Subjects With Relapse of Disease.
The number of participants who relapse following reduced-intensity conditioning haploidentical transplantation at Day 100 and 1 Year.
Measured: Day 100 and 1 Year
Neutrophil Recovery
The average of the number of days that it takes for neutrophil recovery from reduced-intensity conditioning haploidentical transplantation. Neutrophil recovery means absolute neutrophil count of 0.5x10^3 cells/uL.
Measured: Day 30
Platelet Recovery
The average of the number of days that it takes for platelet recovery from reduced-intensity conditioning haploidentical transplantation. Platelet recovery means absolute neutrophil count of 50x10^3 cells/uL.
Measured: Day 30
Acute Graft-versus-host Disease (GVHD) at Day 100 and 180.
The number of participants with graft-versus-host disease using the Center for International Bone Marrow Transplant Research criteria.
Measured: Days 100 and 180
Rates of Chronic GVHD at One-year Post Transplantation.
The number of participants with chronic GVHD at one-year post transplantation using the Center for International Bone Marrow Transplant Research criteria.
Measured: 1 Year
Primary Graft Failure
Number of subjects whose grafts failed to implant.
Measured: Day 30

Timeline

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

8 Dec 20178 Dec 2025

First posted19 May 2017
Study start8 Dec 2017
Primary completion12 Nov 2024
Study completion8 Dec 2025

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.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Hematological MalignancyStudies of the same condition, open and under way.
More trials run by Medical College of WisconsinThe sponsor's other registered studies.
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
Model description: Study subjects will receive different doses of Melphalan during the trial. This is done for safety per FDA recommendations. Subjects younger than 60 years or have will receive doses at 140 mg/m\^2/day while subject 60 years or old or have a Hematopoietic Cell Transplant-Co-morbidity Index (HCT-CI) score of \>3 will receive 70 mg/m\^2/day. The populations will be combined for analysis and reporting.
Masking: None (open label)
Enrolment: 43 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03159702
Sponsor's protocol ID: PRO29507
Status last verified: Jan 2026
First submitted: 17 May 2017
Last updated: 27 Jan 2026
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Publications

Van Besien K, Devine S, Wickrema A, Jessop E, Amin K, Yassine M, Maynard V, Stock W, Peace D, Ravandi F, Chen YH, Hoffman R, Sossman J. Regimen-related toxicity after fludarabine-melphalan conditioning: a prospective study of 31 patients with hematologic malignancies. Bone Marrow Transplant. 2003 Sep;32(5):471-6. doi: 10.1038/sj.bmt.1704166.
PubMed 12942092
Brammer JE, Khouri I, Gaballa S, Anderlini P, Tomuleasa C, Ahmed S, Ledesma C, Hosing C, Champlin RE, Ciurea SO. Outcomes of Haploidentical Stem Cell Transplantation for Lymphoma with Melphalan-Based Conditioning. Biol Blood Marrow Transplant. 2016 Mar;22(3):493-8. doi: 10.1016/j.bbmt.2015.10.015. Epub 2015 Oct 20.
PubMed 26497906

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 27 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Propylene Glycol-Free Melphalan HCl (EVOMELA®) in Combination With Fludarabine and Total Body Irradiation Based Reduced Intensity Conditioning for Haploidentical Transplantation
ClinicalTrials.gov ID: NCT03159702
Acronym / sponsor ID: PRO29507
Conditions: Hematological Malignancy, Multiple Myeloma
Keywords: hematological malignancy, EVOMELA, Melphalan HCl, Total Body Irradiation, Reduced Intensity Conditioning, Haploidentical Transplantation, Fludarabine, Hematologic Diseases
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 43 participants (actual)
Lead sponsor: Medical College of WisconsinUniversity, hospital or other
Study start: 8 Dec 2017 (actual)
Primary completion: 12 Nov 2024 (actual)
Study completion: 8 Dec 2025 (actual)
First posted: 19 May 2017 (actual)
Results: Posted 27 Jan 2026

Clinical summary

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

Detailed description

OVERVIEW:

Reduced-intensity conditioning (RIC) transplantation has emerged as an attractive alternative for these populations.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Study subjects will receive different doses of Melphalan during the trial. This is done for safety per FDA recommendations. Subjects younger than 60 years or have will receive doses at 140 mg/m^2/day while subject 60 years or old or have a Hematopoietic Cell Transplant-Co-morbidity Index (HCT-CI) score of >3 will receive 70 mg/m^2/day. The populations will be combined for analysis and reporting.

Arm	Type	Receives
MEL/FLU and Total-Body Irradiation (TBI)	Experimental	Drug: Evomela, Drug: Fludarabine, Radiation: Total Body Irradiation, Other: Haploidentical Hematopoietic Cell TransplantationFor patients who are < 60 years. * Melphalan: 140 mg/m2/day IV on Day: -6 * Fludarabine: 40 mg/ m2/day IV Days: -5 -4, -3, -2 (Adults: creatinine clearance (CrCl) may be estimated by the Cockcroft Formula: CrCl = [(140-age) x weight (kg) x 0.85 (for women only)]/ [72 x creat (mg/dl)].) * TBI: 200 cGy Day: -1. For patients who are ≥60 years and/or Hematopoietic Cell Transplant-Co-morbidity Index (HCT-CI) score of >3 (at the discretion of treating physician will have an option to receive): * Melphalan: 70 mg/m2/day IV on Day -6. * Fludarabine: 40 mg/m2/day IV Days -5, -4, -3, -2. * TBI: 200 cGy; Days -1.

Who may qualify

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

Key inclusion criteria (12 listed)

Patients with a diagnosis of hematological malignancy undergoing a related donor haploidentical HCT.*
Patients aged ≥18 are eligible.
Bilirubin ≤ 2 x the upper limit of normal (ULN). For patients with Gilbert's syndrome or suspected mild veno-occlusive disease, bilirubin ≤ 3 x ULN is permitted.
Adequate renal function as defined by a serum creatinine clearance of > 30 mL/min calculated by Cockcroft-Gault equation.
Left ventricular ejection fraction ≥40%. No uncontrolled arrhythmias or New York Heart Association class III-IV heart failure.

Key exclusion criteria (3 listed)

Patient must not have a healthy, eligible and readily available HLA-identical sibling donor or a volunteer adult unrelated donor (matched at allele-level at HLA-A, -B, -C and -DRB1).
No serious medical or psychiatric illness that could, in the investigator's opinion, potentially interfere with the completion of treatment according to this protocol.\
Presence of active disease in acute myeloid leukemia (AML)/myelodysplastic syndrome (MDS): patients with active disease defined as >5% blasts in bone marrow and/or circulating leukemic blasts in peripheral blood, patients with known active central nervous disease involvement with leukemia/lymphoma or lymphoma patients with progressive disease on clinical and/or radiographic assessment are not eligible for this study.

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
EvomelaAlso: Melphalan140 mg/m^2/day IV on Day -6 for patients who are < 60 years of age. 70 mg/m^2/day IV on Day -6 For patients who are ≥60 years or have a HCT-CI score of >3	Drug	MEL/FLU and Total-Body Irradiation (TBI)
FludarabineAlso: Fludara40 mg/ m^2/day intravenous on Days: -5 -4, -3, -2	Drug	MEL/FLU and Total-Body Irradiation (TBI)
Total Body Irradiation200 cGy on Day: -1	Radiation	MEL/FLU and Total-Body Irradiation (TBI)
Haploidentical Hematopoietic Cell TransplantationThis is a procedure that uses healthy blood-forming cells from a half-matched donor, typically a family member, to replace a patient's unhealthy ones.	Other	MEL/FLU and Total-Body Irradiation (TBI)

Primary outcome

Progression-free Survival (PFS) of Participants With Hematological Malignancies Undergoing Treatment.
Time frame: 1 year
Progression-free survival (PFS) is defined as the interval from the date of transplantation to the earlier of the following events: (1) the first documented objective disease progression; (2) death from any cause. Subjects without documented PD/death will be censored at the earliest of the of the following times: (1) the starting time of a new treatment other than the study treatment; (2) the last efficacy assessment date.
Serious Adverse Events (SAE).
Time frame: 2 Years
An SAE is defined as any untoward medical occurrence at any dose, including death, life threatening, hospitalization, disability/incapacity, medically important event. The measure of this outcome is the number of participants with SAEs.

8 secondary outcomes

Nonrelapse Mortality Rate.
Time frame: 1 Year
Overall Survival
Time frame: 1 Year and 2 Year
Number of Subjects With Relapse of Disease.
Time frame: Day 100 and 1 Year
Neutrophil Recovery
Time frame: Day 30
Platelet Recovery
Time frame: Day 30
Acute Graft-versus-host Disease (GVHD) at Day 100 and 180.
Time frame: Days 100 and 180
Rates of Chronic GVHD at One-year Post Transplantation.
Time frame: 1 Year
Primary Graft Failure
Time frame: Day 30

Results and safety

Results posted to the registry on 27 Jan 2026, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MEL/FLU and Total-Body Irradiation (TBI)	43	43

Primary outcome: Progression-free Survival (PFS) of Participants With Hematological Malignancies Undergoing Treatment.

Time frame: 1 year. Count of participants. Unit: Participants

Measure	MEL/FLU and Total-Body Irradiation (TBI) n = 43
Value	17

Primary outcome: Serious Adverse Events (SAE).

Time frame: 2 Years. Count of participants. Unit: Participants

Measure	MEL/FLU and Total-Body Irradiation (TBI) n = 43
Value	12

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: 2 Years. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MEL/FLU and Total-Body Irradiation (TBI)	12 of 43 (27.9%)	43 of 43 (100%)	18 of 43

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2026.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Background: PubMed 12942092Van Besien K, Devine S, Wickrema A, Jessop E, Amin K, Yassine M, Maynard V, Stock W, Peace D, Ravandi F, Chen YH, Hoffman R, Sossman J. Regimen-related toxicity after fludarabine-melphalan conditioning: a prospective study of 31 patients with hematologic malignancies. Bone Marrow Transplant. 2003 Sep;32(5):471-6. doi: 10.1038/sj.bmt.1704166.
Background: PubMed 26497906Brammer JE, Khouri I, Gaballa S, Anderlini P, Tomuleasa C, Ahmed S, Ledesma C, Hosing C, Champlin RE, Ciurea SO. Outcomes of Haploidentical Stem Cell Transplantation for Lymphoma with Melphalan-Based Conditioning. Biol Blood Marrow Transplant. 2016 Mar;22(3):493-8. doi: 10.1016/j.bbmt.2015.10.015. Epub 2015 Oct 20.
Individual participant dataSharing planned: No

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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.

Mehdi Hamadani principal investigator

Medical College of Wisconsin

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Evomela, Fludarabine and Total Body Irradiation in people with Hematological Malignancy and Multiple Myeloma, run by Medical College of Wisconsin 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 12 inclusion and 3 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 27 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?

Yes. Results are posted in the registry (first posted 27 Jan 2026). 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?

Progression-free Survival (PFS) of Participants With Hematological Malignancies Undergoing Treatment. (time frame: 1 year). The study lists 2 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 NCT03159702, which also lists 2 linked publications.

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 27 Jan 2026.